Clinical Trials List
Protocol NumberD6960C00005
Not yet recruiting
2026-06-01 - 2028-12-31
Phase II
Not yet recruiting1
Recruiting1
A phase IIb trial (ARGiNAUT) evaluating the efficacy, safety, and tolerability of AZD8965 in patients with idiopathic pulmonary fibrosis (IPF).
-
Trial Applicant
-
Sponsor
AstraZeneca Taiwan Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/09/21
Investigators and Locations
Co-Principal Investigator
- Han-Lin Hsu Division of Thoracic Medicine
- Yu-Tien Tzeng Division of Thoracic Medicine
- Jer-Hwa Chang Division of Thoracic Medicine
- Chih-Hsin Lee Division of Thoracic Medicine
- 楊善堯 Division of Thoracic Medicine
- Kuan-Jen Bai Division of Thoracic Medicine
- Shian-Jiun Lin Division of Thoracic Medicine
- 石智元 Division of Thoracic Medicine
Co-Principal Investigator
- 黃丞正 Division of Thoracic Medicine
- 王振宇 Division of Thoracic Medicine
- WEI-WEN LIN Division of Cardiovascular Diseases
- 蕭亦均 Division of Thoracic Medicine
- 陳昱瑋 Division of Cardiovascular Diseases
Co-Principal Investigator
- 鄭孟軒 Division of Thoracic Medicine
- Wei-An Chang Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- Hung-Ling Huang Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
- 李岱晃 Division of Thoracic Medicine
- jong rung Tsai Division of Thoracic Medicine
Co-Principal Investigator
- 陶啟偉 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Horng-Chyuan Lin
Co-Principal Investigator
- 羅君禹 Division of Thoracic Medicine
- Shu-Min Lin Division of Infectious Disease
- 黃建達 Division of Thoracic Medicine
- 張博瑞 Division of Thoracic Medicine
- 張美元 Division of Thoracic Medicine
- 謝孟亨 Division of Infectious Disease
- 林倡葦 Division of Infectious Disease
- 李忠恕 Division of Infectious Disease
- 胡漢忠 Division of Infectious Disease
- 吳秉宸 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Idiopathic pulmonary fibrosis
Objectives
The study aimed to evaluate the efficacy, safety, and tolerability of three different doses of AZD8965 (administered twice daily (BID)) compared to placebo in IPF subjects, including those receiving antifibrotic therapy (nintedanib, pirfenidone, nerandomilast) (whether alone or in combination) or those not receiving antifibrotic therapy.
Test Drug
AZD8965 Film-Coated Tablet
Active Ingredient
AZD8965
AZD8965
AZD8965
Dosage Form
Film-coated tablets
Dosage
6 mg
20 mg
20 mg
Endpoints
Assess the clinical efficacy of AZD8965 compared to placebo in terms of the absolute change in forced expiratory vital capacity (FVC) (mL) since baseline at week 24.
Congregation: All subjects randomly assigned to receive ≥ 1 dose of AZD8965 or placebo.
Measure: Change in FVC (mL) since baseline at week 24.
Congregation-level summary assessment measure: Difference in mean change in FVC since baseline between AZD8965 and placebo.
Comorbidity strategy: Define three comorbidities: 1) Change in planned antifibrotic therapy; 2) Discontinuation of investigational drug (IMP) treatment; 3) Death or lung transplantation.
For comorbidities (ICH E9 [R1]), the following strategies will be employed:
• Comorbidities (excluding death or lung transplantation) will be handled through a treatment policy strategy (i.e., the occurrence of a comorbidity is considered irrelevant to the definition of the treatment outcome of interest: the value of the variable of interest will be used regardless of whether a comorbidity occurs).
• Comorbidities such as death or lung transplantation will be handled through a composite strategy, where the FVC value will be replaced based on the 2.5 percentile of observations within the same treatment group.
Supporting estimation target: Treatment duration.
Congregation: All subjects randomly assigned to receive ≥ 1 dose of AZD8965 or placebo.
Measure: Change in FVC (mL) since baseline at week 24.
Congregation-level summary assessment measure: Difference in mean change in FVC since baseline between AZD8965 and placebo.
Comorbidity strategy: Define three comorbidities: 1) Change in planned antifibrotic therapy; 2) Discontinuation of investigational drug (IMP) treatment; 3) Death or lung transplantation.
For comorbidities (ICH E9 [R1]), the following strategies will be employed:
• Comorbidities (excluding death or lung transplantation) will be handled through a treatment policy strategy (i.e., the occurrence of a comorbidity is considered irrelevant to the definition of the treatment outcome of interest: the value of the variable of interest will be used regardless of whether a comorbidity occurs).
• Comorbidities such as death or lung transplantation will be handled through a composite strategy, where the FVC value will be replaced based on the 2.5 percentile of observations within the same treatment group.
Supporting estimation target: Treatment duration.
Inclution Criteria
Subjects are eligible for inclusion in this trial only if they meet all the following inclusion criteria:
Age 1. Subjects must be ≥ 40 years old at the time of signing the subject consent form.
Subject Type and Disease Characteristics
2. Subjects must be diagnosed with IPF according to the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines, and have confirmed common interstitial pneumonia (UIP) or a probable UIP morphology by a central evaluation of a high-resolution computed tomography (HRCT) scan of the chest performed within the 12 months prior to randomization. Subjects with inconclusive HRCT results are eligible if their previous surgical lung section or bronchopulmonary frozen section histopathology confirms UIP or a probable UIP. Subjects with surrogate diagnostic HRCT results are eligible if their previous surgical lung section or bronchopulmonary frozen section histopathology confirms UIP. All histopathological reports confirming an IPF diagnosis through local interpretation must be retained in the subject's original file and the results must be recorded in the eCRF.
3. Subjects with IPF who have been receiving a stable dose of a locally approved antifibrotic therapy (pirfenidone, nintedanib, or nerandomilast) at a stable dose for at least 12 weeks prior to screening (whether alone or with permitted concomitant therapy, see Section 6.1.1) and maintained a stable dose during screening, or subjects with IPF who have not received local standard care (i.e., pirfenidone, nintedanib, or nerandomilast) for at least 12 weeks prior to screening and during screening (for any reason).
4. FVC ≥ 45% of predicted normal. If the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria as assessed by central interpretation, a maximum of 2 retests are permitted during screening.
5. Before randomization at the second follow-up visit, the predicted FVC % as assessed by central interpretation should not be more than 8% higher than the predicted FVC % at the screening follow-up visit. If a subject's FVC value at the second follow-up visit is more than 8% higher than the FVC value at screening, rescreening may be performed.
6. Forced expiratory volume in one second (FEV1)/FVC ≥ lower limit of normal (LLN). If, as assessed by central interpretation, the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria, retesting is permitted up to 2 times during the screening period.
7. Heme-corrected carbon monoxide diffusing capacity (DLCO) ≥ 25% of the predicted normal value. If the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria, retesting is permitted up to 2 times during the screening period. Heme-corrected DLCO results from tests conducted within the 6 months prior to screening are acceptable and do not need to be repeated during screening.
Gender and Contraception/Barrier Requirements
8. The contraceptive method used by the subject or their partner should comply with local regulations regarding contraceptive methods for clinical trial subjects.
a) Male Subjects:
o. Unsterilized men who have sexual intercourse with a woman of fertility (WOCBP) from randomization until at least 3 days after the last dose of investigational drug (IMP) must use a condom during intercourse. Male subjects are considered unsterilized unless they have previously undergone bilateral orchiectomy, which should be confirmed by medical evaluation and recorded in the subject's medical record. If a man has undergone vasectomy, and the procedure is recorded in the subject's medical record, and his semen is confirmed to be sperm-free by a physician at two independent time points at least 30 days apart at the completion of the procedure, he will be considered unsterilized.
o The WOCBP partner of unsterilized male participants must consent to the use of a highly effective method of contraception, and must have been consistently using an approved method of contraception for at least 3 months prior to the second follow-up visit, and continue using it throughout the trial until 3 days after the participant receives the last dose of IMP (Table 6).
o Unsterilized male participants should use the acceptable method of contraception described in Table 6 to avoid pregnancy.
o Complete and continuous abstinence from sexual activity with WOCBP is an acceptable method of contraception only when it aligns with the participant's habitual lifestyle.
b) Female participants:
(i) Women under 55 years of age at screening must meet one of the following criteria to be eligible to participate in the trial:
o Postmenopausal, defined as the absence of menstruation for ≥ 12 months after cessation of all exogenous hormone therapy, and FSH concentrations within the postmenopausal range (acceptable FSH history).
o Patients must have undergone permanent sterilization, including hysterectomy, bilateral oophorectomy, and bilateral salpingectomy, at least 6 weeks prior to screening, as confirmed by medical records or hormone level monitoring. Bilateral tubal ligation is not acceptable.
o If the patient is a WOCBP and has sexual intercourse with a potentially fertile male partner, they must be willing to use a low-user-dependency, non-hormonal, highly effective contraceptive method (Table 7) throughout the trial period until 30 days after the last dose of IMP. WOCBP patients should have consistently used their chosen method of contraception for at least 3 months prior to the first dose, and their male partner must use condoms during intercourse throughout the trial period.
(ii) Women aged ≥ 55 years must be postmenopausal unless sterilized. Postmenopause is defined as ≥ 12 months of amenorrhea without other cause after cessation of all exogenous hormone therapy.
(iii) Pregnancy Testing (WOCBP Only): All WOCBP patients must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before randomization and IMP administration (see SoA Table 1).
Informed Consent Form
9. Able to provide a signed informed consent form as described in Appendix A.
10. Subjects are willing and able to:
(a) Comply with the trial protocol requirements, including being able to read, write, and fluently understand all translated versions of subject-specific questionnaires.
(b) Attend all trial follow-ups and comply with all trial procedures.
11. Selectivity: Provide a signed and dated selective genomics study information and consent form before collecting specimens for selective genomics studies to support the genomics project (see Appendix D2).
12. Selectivity: Provide a signed and dated HRCT sub-trial written consent form before proceeding with sub-trial procedures (if applicable) (see Section 8.2.2.2).
13. Selectivity: Before proceeding with the sub-trial procedure, provide a signed and dated written consent form for the PK sub-trial (applicable to subjects in the relevant country) (see Section 8.5.1.3).
Due to the inadequate presentation of Tables 6 and 7 in the system, please refer to the inclusion criteria in the project proposal, Chinese abstract, or subject consent form for details.
Age 1. Subjects must be ≥ 40 years old at the time of signing the subject consent form.
Subject Type and Disease Characteristics
2. Subjects must be diagnosed with IPF according to the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines, and have confirmed common interstitial pneumonia (UIP) or a probable UIP morphology by a central evaluation of a high-resolution computed tomography (HRCT) scan of the chest performed within the 12 months prior to randomization. Subjects with inconclusive HRCT results are eligible if their previous surgical lung section or bronchopulmonary frozen section histopathology confirms UIP or a probable UIP. Subjects with surrogate diagnostic HRCT results are eligible if their previous surgical lung section or bronchopulmonary frozen section histopathology confirms UIP. All histopathological reports confirming an IPF diagnosis through local interpretation must be retained in the subject's original file and the results must be recorded in the eCRF.
3. Subjects with IPF who have been receiving a stable dose of a locally approved antifibrotic therapy (pirfenidone, nintedanib, or nerandomilast) at a stable dose for at least 12 weeks prior to screening (whether alone or with permitted concomitant therapy, see Section 6.1.1) and maintained a stable dose during screening, or subjects with IPF who have not received local standard care (i.e., pirfenidone, nintedanib, or nerandomilast) for at least 12 weeks prior to screening and during screening (for any reason).
4. FVC ≥ 45% of predicted normal. If the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria as assessed by central interpretation, a maximum of 2 retests are permitted during screening.
5. Before randomization at the second follow-up visit, the predicted FVC % as assessed by central interpretation should not be more than 8% higher than the predicted FVC % at the screening follow-up visit. If a subject's FVC value at the second follow-up visit is more than 8% higher than the FVC value at screening, rescreening may be performed.
6. Forced expiratory volume in one second (FEV1)/FVC ≥ lower limit of normal (LLN). If, as assessed by central interpretation, the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria, retesting is permitted up to 2 times during the screening period.
7. Heme-corrected carbon monoxide diffusing capacity (DLCO) ≥ 25% of the predicted normal value. If the initial measurement does not meet the ATS/ERS/JRS/ALAT quality and/or reproducibility criteria, retesting is permitted up to 2 times during the screening period. Heme-corrected DLCO results from tests conducted within the 6 months prior to screening are acceptable and do not need to be repeated during screening.
Gender and Contraception/Barrier Requirements
8. The contraceptive method used by the subject or their partner should comply with local regulations regarding contraceptive methods for clinical trial subjects.
a) Male Subjects:
o. Unsterilized men who have sexual intercourse with a woman of fertility (WOCBP) from randomization until at least 3 days after the last dose of investigational drug (IMP) must use a condom during intercourse. Male subjects are considered unsterilized unless they have previously undergone bilateral orchiectomy, which should be confirmed by medical evaluation and recorded in the subject's medical record. If a man has undergone vasectomy, and the procedure is recorded in the subject's medical record, and his semen is confirmed to be sperm-free by a physician at two independent time points at least 30 days apart at the completion of the procedure, he will be considered unsterilized.
o The WOCBP partner of unsterilized male participants must consent to the use of a highly effective method of contraception, and must have been consistently using an approved method of contraception for at least 3 months prior to the second follow-up visit, and continue using it throughout the trial until 3 days after the participant receives the last dose of IMP (Table 6).
o Unsterilized male participants should use the acceptable method of contraception described in Table 6 to avoid pregnancy.
o Complete and continuous abstinence from sexual activity with WOCBP is an acceptable method of contraception only when it aligns with the participant's habitual lifestyle.
b) Female participants:
(i) Women under 55 years of age at screening must meet one of the following criteria to be eligible to participate in the trial:
o Postmenopausal, defined as the absence of menstruation for ≥ 12 months after cessation of all exogenous hormone therapy, and FSH concentrations within the postmenopausal range (acceptable FSH history).
o Patients must have undergone permanent sterilization, including hysterectomy, bilateral oophorectomy, and bilateral salpingectomy, at least 6 weeks prior to screening, as confirmed by medical records or hormone level monitoring. Bilateral tubal ligation is not acceptable.
o If the patient is a WOCBP and has sexual intercourse with a potentially fertile male partner, they must be willing to use a low-user-dependency, non-hormonal, highly effective contraceptive method (Table 7) throughout the trial period until 30 days after the last dose of IMP. WOCBP patients should have consistently used their chosen method of contraception for at least 3 months prior to the first dose, and their male partner must use condoms during intercourse throughout the trial period.
(ii) Women aged ≥ 55 years must be postmenopausal unless sterilized. Postmenopause is defined as ≥ 12 months of amenorrhea without other cause after cessation of all exogenous hormone therapy.
(iii) Pregnancy Testing (WOCBP Only): All WOCBP patients must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before randomization and IMP administration (see SoA Table 1).
Informed Consent Form
9. Able to provide a signed informed consent form as described in Appendix A.
10. Subjects are willing and able to:
(a) Comply with the trial protocol requirements, including being able to read, write, and fluently understand all translated versions of subject-specific questionnaires.
(b) Attend all trial follow-ups and comply with all trial procedures.
11. Selectivity: Provide a signed and dated selective genomics study information and consent form before collecting specimens for selective genomics studies to support the genomics project (see Appendix D2).
12. Selectivity: Provide a signed and dated HRCT sub-trial written consent form before proceeding with sub-trial procedures (if applicable) (see Section 8.2.2.2).
13. Selectivity: Before proceeding with the sub-trial procedure, provide a signed and dated written consent form for the PK sub-trial (applicable to subjects in the relevant country) (see Section 8.5.1.3).
Due to the inadequate presentation of Tables 6 and 7 in the system, please refer to the inclusion criteria in the project proposal, Chinese abstract, or subject consent form for details.
Exclusion Criteria
Subjects are ineligible to participate in the trial if they meet any of the following criteria: Medical Condition and Diagnostic Assessment
1. Interstitial lung disease (ILD) other than IPF.
2. The degree of emphysema exceeds the degree of fibrosis changes on a chest HRCT scan (as determined by central assessment).
3. An acute exacerbation of IPF occurred within 8 weeks prior to screening or during screening. Rescreening is permitted after the trial administrator determines that the subject has recovered from the exacerbation.
4. A lower respiratory tract infection requiring treatment (e.g., antibiotic use) occurred within 4 weeks prior to screening or during screening. Rescreening is permitted after recovery from the infection.
5. Chronic or persistent neurological disorders (including, but not limited to, epilepsy or dementia) that may confound the assessment of the potential neurological effects of arginase inhibitors, or any clinically significant past or persistent mental illness.
6. A QT interval (QTcF) corrected for Fridericia > 450 ms, with known long QT syndrome, high-degree II-III atrioventricular (AV) block, sinoatrial node dysfunction with clinically significant sinus pauses and no pacemaker therapy, or ventricular arrhythmia requiring continuous treatment.
7. Subjects with atrial fibrillation/flutter and poorly controlled ventricular rate (i.e., resting heart rate > 100 bpm), or who have not received stable anticoagulant therapy for at least 8 weeks (unless contraindicated). A maximum of 2 heart rate retests are allowed during screening, and subjects will be eligible if any retested heart rate is < 100 bpm.
8. An acute coronary syndrome/acute myocardial infarction, unstable angina ± percutaneous coronary intervention or coronary artery bypass grafting performed within 6 months prior to screening or during screening.
9. Heart failure, defined as New York Heart Association (NYHA) Class III or IV.
10. History of any clinically significant disease or disorder other than IPF, which the trial administrator determines may put the subject at risk in participating in the trial, or may affect the outcome or the subject's ability to participate in the trial.
11. History of urea cycle disorders (e.g., severe deficiency of amiodarone synthase I, ornithine aminotransferase, arginine succinate synthase, arginine succinate dissolvingase, N-acetylglucosamine synthase, or argininase).
12. Liver function tests at screening, defined as:
(a) Aspartate transaminase (AST) ≥ 2.5 × Upper Limit of Normal (ULN), or
(b) Alanine transaminase (ALT) ≥ 2.5 × ULN, or
(c) Total bilirubin (TBL) ≥ 1.5 × ULN (excluding Gilbert's syndrome). A maximum of two retests are allowed during the screening period.
13. Renal function at screening, defined as eGFR < 45 mL/min/1.73 m² calculated using the CKD-EPI formula (2021).
A maximum of two retests are allowed during the screening period.
14. Heme at screening, defined as heme < 10 g/dL (100 g/L).
A maximum of two retests are allowed during the screening period.
15. Received a red blood cell transfusion for anemia within 3 months prior to or during the screening period.
16. Known history of allergy to any component of AZD8965 tablets (see Section 3.2.2 of the AZD8965 Principal Investigator's Manual).
17. History of organ transplantation, or likely to receive a lung transplant within the next 6 months.
18. Underwent or planned to undergo major surgery within 6 weeks prior to randomization (as determined by the trial principal investigator). Subjects may be rescreened 6 weeks after surgery or after full recovery (whichever is later).
19. Newly diagnosed malignancy/recurrent malignancy within the past 5 years (excluding cervical carcinoma in situ, completely resected non-melanoma skin cancer with no evidence of recurrence [e.g., basal cell carcinoma, squamous cell carcinoma], completely resected ductal carcinoma in situ, papillary thyroid cancer that has received complete treatment, and low-risk prostate cancer under active surveillance).
20. History of relevant viral infection, including any of the following:
(a) HIV infection or current HIV antiretroviral therapy, or a positive HIV test result at screening.
(b) Positive hepatitis A IgM at or during screening. Retesting is permitted once during screening (after the trial administrator deems the subject to have fully recovered).
(c) Evidence of active liver disease and/or evidence of chronic liver disease secondary to viral hepatitis at screening. Subjects will be excluded from the trial if any of the following criteria are met:
(i) The subject has a positive hepatitis C antibody test result, unless hepatitis C virus (HCV) RNA concentration is undetectable prior to randomization.
• Note that if the subject has completed HCV treatment, RNA concentration can only be assessed more than 12 weeks after the end of treatment.
(ii) The subject has a positive hepatitis B virus (HBV) surface antigen test result.
• If the subject has a history of HBV and/or a positive HBV core antibody test result, HBV DNA polymerase chain reaction (PCR) must be negative for inclusion.
• Subjects who have been vaccinated against HBV (i.e., negative for anti-hepatitis B core antibody (HBcAb)) are eligible for inclusion.
21. Subjects have active tuberculosis (TB) or are currently receiving treatment for active TB.
Other exclusion criteria:
22. WOCBP patients who are pregnant or intend to become pregnant during the trial, breastfeeding, or who do not wish to use a highly effective method of contraception (see inclusion criterion 8) throughout the trial.
23. Unsterilized male subjects who have had sexual intercourse with a WOCBP partner and do not agree to use a highly effective method of contraception from day 1 of administration until 3 days after the last dose of IMP.
24. Participants in the planning and/or execution of this trial (applicable to AstraZeneca employees, Contract Research Organization (CRO) employees, and/or trial center personnel).
25. Currently enrolled in another interventional clinical trial, or having recently completed an interventional trial, and receiving the last dose of IMP less than 5 half-lives prior to screening.
1. Interstitial lung disease (ILD) other than IPF.
2. The degree of emphysema exceeds the degree of fibrosis changes on a chest HRCT scan (as determined by central assessment).
3. An acute exacerbation of IPF occurred within 8 weeks prior to screening or during screening. Rescreening is permitted after the trial administrator determines that the subject has recovered from the exacerbation.
4. A lower respiratory tract infection requiring treatment (e.g., antibiotic use) occurred within 4 weeks prior to screening or during screening. Rescreening is permitted after recovery from the infection.
5. Chronic or persistent neurological disorders (including, but not limited to, epilepsy or dementia) that may confound the assessment of the potential neurological effects of arginase inhibitors, or any clinically significant past or persistent mental illness.
6. A QT interval (QTcF) corrected for Fridericia > 450 ms, with known long QT syndrome, high-degree II-III atrioventricular (AV) block, sinoatrial node dysfunction with clinically significant sinus pauses and no pacemaker therapy, or ventricular arrhythmia requiring continuous treatment.
7. Subjects with atrial fibrillation/flutter and poorly controlled ventricular rate (i.e., resting heart rate > 100 bpm), or who have not received stable anticoagulant therapy for at least 8 weeks (unless contraindicated). A maximum of 2 heart rate retests are allowed during screening, and subjects will be eligible if any retested heart rate is < 100 bpm.
8. An acute coronary syndrome/acute myocardial infarction, unstable angina ± percutaneous coronary intervention or coronary artery bypass grafting performed within 6 months prior to screening or during screening.
9. Heart failure, defined as New York Heart Association (NYHA) Class III or IV.
10. History of any clinically significant disease or disorder other than IPF, which the trial administrator determines may put the subject at risk in participating in the trial, or may affect the outcome or the subject's ability to participate in the trial.
11. History of urea cycle disorders (e.g., severe deficiency of amiodarone synthase I, ornithine aminotransferase, arginine succinate synthase, arginine succinate dissolvingase, N-acetylglucosamine synthase, or argininase).
12. Liver function tests at screening, defined as:
(a) Aspartate transaminase (AST) ≥ 2.5 × Upper Limit of Normal (ULN), or
(b) Alanine transaminase (ALT) ≥ 2.5 × ULN, or
(c) Total bilirubin (TBL) ≥ 1.5 × ULN (excluding Gilbert's syndrome). A maximum of two retests are allowed during the screening period.
13. Renal function at screening, defined as eGFR < 45 mL/min/1.73 m² calculated using the CKD-EPI formula (2021).
A maximum of two retests are allowed during the screening period.
14. Heme at screening, defined as heme < 10 g/dL (100 g/L).
A maximum of two retests are allowed during the screening period.
15. Received a red blood cell transfusion for anemia within 3 months prior to or during the screening period.
16. Known history of allergy to any component of AZD8965 tablets (see Section 3.2.2 of the AZD8965 Principal Investigator's Manual).
17. History of organ transplantation, or likely to receive a lung transplant within the next 6 months.
18. Underwent or planned to undergo major surgery within 6 weeks prior to randomization (as determined by the trial principal investigator). Subjects may be rescreened 6 weeks after surgery or after full recovery (whichever is later).
19. Newly diagnosed malignancy/recurrent malignancy within the past 5 years (excluding cervical carcinoma in situ, completely resected non-melanoma skin cancer with no evidence of recurrence [e.g., basal cell carcinoma, squamous cell carcinoma], completely resected ductal carcinoma in situ, papillary thyroid cancer that has received complete treatment, and low-risk prostate cancer under active surveillance).
20. History of relevant viral infection, including any of the following:
(a) HIV infection or current HIV antiretroviral therapy, or a positive HIV test result at screening.
(b) Positive hepatitis A IgM at or during screening. Retesting is permitted once during screening (after the trial administrator deems the subject to have fully recovered).
(c) Evidence of active liver disease and/or evidence of chronic liver disease secondary to viral hepatitis at screening. Subjects will be excluded from the trial if any of the following criteria are met:
(i) The subject has a positive hepatitis C antibody test result, unless hepatitis C virus (HCV) RNA concentration is undetectable prior to randomization.
• Note that if the subject has completed HCV treatment, RNA concentration can only be assessed more than 12 weeks after the end of treatment.
(ii) The subject has a positive hepatitis B virus (HBV) surface antigen test result.
• If the subject has a history of HBV and/or a positive HBV core antibody test result, HBV DNA polymerase chain reaction (PCR) must be negative for inclusion.
• Subjects who have been vaccinated against HBV (i.e., negative for anti-hepatitis B core antibody (HBcAb)) are eligible for inclusion.
21. Subjects have active tuberculosis (TB) or are currently receiving treatment for active TB.
Other exclusion criteria:
22. WOCBP patients who are pregnant or intend to become pregnant during the trial, breastfeeding, or who do not wish to use a highly effective method of contraception (see inclusion criterion 8) throughout the trial.
23. Unsterilized male subjects who have had sexual intercourse with a WOCBP partner and do not agree to use a highly effective method of contraception from day 1 of administration until 3 days after the last dose of IMP.
24. Participants in the planning and/or execution of this trial (applicable to AstraZeneca employees, Contract Research Organization (CRO) employees, and/or trial center personnel).
25. Currently enrolled in another interventional clinical trial, or having recently completed an interventional trial, and receiving the last dose of IMP less than 5 half-lives prior to screening.
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
360 participants
