Clinical Trials List
Protocol NumberIG3018-23-02-01
Active
2025-05-01 - 2026-01-30
Phase I
Recruiting4
ICD-10E79.0
Hyperuricemia without signs of inflammatory arthritis and tophaceous disease
ICD-10R73.9
Hyperglycemia, unspecified
ICD-10R78.71
Abnormal lead level in blood
ICD-10R78.79
Finding of abnormal level of heavy metals in blood
ICD-10R78.89
Finding of other specified substances, not normally found in blood
ICD-10R79.0
Abnormal level of blood mineral
ICD-10R79.89
Other specified abnormal findings of blood chemistry
ICD-10R79.9
Abnormal finding of blood chemistry, unspecified
ICD-9790.6
Other abnormal blood chemistry
A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects with Hyperuricemia with or without Chronic Kidney Disease
-
Sponsor
Tigermed Australia Pty Limited.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yao-Fan Fang 無
- Yun Chen Tsai 無
- Ping-Han Tsai 無
- 陳彥輔 無
- 蕭朝陽 無
- 楊皇煜 無
- Chen-I Hsieh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tzn-Min Lin
Co-Principal Investigator
- 李向嚴 無
- Chi-Ching Chang 無
- Chih-Chin Kao Division of Nephrology
- Hsi-Hsien Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Kidney Disease
Objectives
Primary Objective of Part 1
1. To assess the safety and tolerability of IG3018 in hyperuricemia
subjects without CKD.
2. To assess the primary efficacy of IG3018 in hyperuricemia subjects
without CKD.
Test Drug
tablet
Active Ingredient
MANGANESE DIOXIDE
Dosage Form
110
Dosage
250mg/tablet, 500mg/tablet
Endpoints
Primary Endpoints of Part 1
1. Incidence of reported adverse events (AEs).
2. Clinically significant changes in vital signs, physical examination,
laboratory tests, 12-lead electrocardiogram (ECG).
3. The proportions of change from baseline in serum uric acid to
normal level (≤ 0.36 mmol/L) following 4 weeks treatment with
IG3018 in each dose.
1. Incidence of reported adverse events (AEs).
2. Clinically significant changes in vital signs, physical examination,
laboratory tests, 12-lead electrocardiogram (ECG).
3. The proportions of change from baseline in serum uric acid to
normal level (≤ 0.36 mmol/L) following 4 weeks treatment with
IG3018 in each dose.
Inclution Criteria
Subjects must meet all the following criteria to be included in the study:
1. Male or female, aged 18 to 75 years (both inclusive).
2. According to the investigator's judgment, eGFR must be met as:
Part 1 only: subjects without CKD and have eGFR ≥ 60
mL/minute/1.73 m2 at screening phase;
Part 2 only: subjects with advanced predialysis CKD (Stage 3a, 3b
and Stage 4) have eGFR≥15 and <60 mL/minute/1.73 m2 at screening
phase.
3. The serum uric acid level for subjects need to meet any of the
following:
For subjects already on ULT within 2 weeks prior to the screening visit, the
serum uric acid would be measured during the screening visit/phase, and
then at the end of the run-in phase, prior to confirming their eligibility.
Subjects with ULT within 2 weeks before screening has fasting serum uric
acid ≥ 0.48 mmol/L at the end of run-in phase.
For subjects without ULT in 2 weeks prior to screening visit，the serum
uric acid should be measured twice on 2 different days (at least 24 hours
apart) prior to confirming their eligibility. Subjects without ULT within 2
weeks before screening has fasting serum uric acid ≥ 0.48 mmol/L at
screening phase.
4. Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 (both inclusive) at
screening.
5. Female subjects of child-bearing potential must agree to use highly
effective contraceptive methods and must abstain from egg collection
or donation from the screening phase to 90 days after the last dose of
the IMP. And the male partner of a female subject also needs to agree
to use highly effective method of birth control during this phase
(Appendix 1).
6. Male subjects considered fertile must agree to not donate sperm, and
take effective contraceptive methods from the screening phase to 90
days after the last dose of the IMP. And the female partner of male
subjects also needs to agree to use a highly effective method of female
contraception during this phase (Appendix 1).
7. Able to understand and give signed written informed consent form
(ICF) and willing to comply with all study procedures.
1. Male or female, aged 18 to 75 years (both inclusive).
2. According to the investigator's judgment, eGFR must be met as:
Part 1 only: subjects without CKD and have eGFR ≥ 60
mL/minute/1.73 m2 at screening phase;
Part 2 only: subjects with advanced predialysis CKD (Stage 3a, 3b
and Stage 4) have eGFR≥15 and <60 mL/minute/1.73 m2 at screening
phase.
3. The serum uric acid level for subjects need to meet any of the
following:
For subjects already on ULT within 2 weeks prior to the screening visit, the
serum uric acid would be measured during the screening visit/phase, and
then at the end of the run-in phase, prior to confirming their eligibility.
Subjects with ULT within 2 weeks before screening has fasting serum uric
acid ≥ 0.48 mmol/L at the end of run-in phase.
For subjects without ULT in 2 weeks prior to screening visit，the serum
uric acid should be measured twice on 2 different days (at least 24 hours
apart) prior to confirming their eligibility. Subjects without ULT within 2
weeks before screening has fasting serum uric acid ≥ 0.48 mmol/L at
screening phase.
4. Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 (both inclusive) at
screening.
5. Female subjects of child-bearing potential must agree to use highly
effective contraceptive methods and must abstain from egg collection
or donation from the screening phase to 90 days after the last dose of
the IMP. And the male partner of a female subject also needs to agree
to use highly effective method of birth control during this phase
(Appendix 1).
6. Male subjects considered fertile must agree to not donate sperm, and
take effective contraceptive methods from the screening phase to 90
days after the last dose of the IMP. And the female partner of male
subjects also needs to agree to use a highly effective method of female
contraception during this phase (Appendix 1).
7. Able to understand and give signed written informed consent form
(ICF) and willing to comply with all study procedures.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from the
study:
1. Prior uricase/recombinant uricase (such as Rasburicase or Pegloticase)
therapy within 2 weeks prior to screening or last dose of therapy< 5
times the half-life (whichever is longer).
2. Subjects who have acute gout flares requiring treatment within 4 weeks
prior to or during screening.
3. Major surgery within 3 months prior to the first administration.
4. History of malignant tumors within 6 months prior to screening.
5. Subjects within the last 3 months have: myocardial infarction, angina,
percutaneous transluminal coronary angioplasty, coronary artery
bypass grafting, cerebral infarction, cerebral hemorrhage,
subarachnoid hemorrhage, or transient ischemia attack.
6. Subjects who are on other urate-lowering medication (allopurinol,
febuxostat, probenecid and benzbromarone) and cannot stop during the
study periods included in the run-in phase.
7. Subject with underlying medical conditions requiring changes or
introduction of drugs that have the potential impact on the serum uric
acid levels (e.g., salicylic acids, diuretics, angiotensin receptor
blockers, etc.) within at least 1 month prior the screening phase.
8. History of gastrointestinal (GI) surgery, including gastric sleeve,
colostomy/enterostomy, Roux-en-Y or gastric banding (unless gastric
band removed for a minimum of 12 months prior to screening.
9. History of GI diseases, including gastrointestinal bleeding moderate to
severe gastrointestinal dysfunction, moderate to severe chronic
constipation for a minimum of 3 months prior to screening, or newly
diagnosed peptic or duodenal ulcer diseases within 4 weeks prior to
screening.
10. Chronic use of parenteral nutrition including manganese within 3
months prior to screening.
11. Subjects who have the history of manganese toxicity or excessive
exposure to manganese (i.e., having worked in a mine, foundry,
smelter, dry cell battery manufacturing facility) within 2 months prior
to screening.
12. Inability to swallow oral medications.
13. Received treatment with or exposure to an investigational drug or
device within 30 days of signing informed consent.
14. Subjects with one of positive results of HIV virus, or positive hepatitis
B virus surface antigen (HBsAg) and the number of copies of hepatitis
B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500
copies, or the lower limit of the positive detection value of the study
site) at screening, or HBsAg (-), hepatitis B core antibody (HBcAb)
(+) and the number of copies of HBV DNA ≥ 500 IU/mL (or 2500
copies, or the lower limit of the positive detection value of the study
site) after treatment of HBV infection, or positive hepatitis C antibody
(HCV-Ab), and hepatitis C virus (HCV) ribonucleic acid (RNA)
≥upper limit of normal (ULN) of the study site during screening phase.
study:
1. Prior uricase/recombinant uricase (such as Rasburicase or Pegloticase)
therapy within 2 weeks prior to screening or last dose of therapy< 5
times the half-life (whichever is longer).
2. Subjects who have acute gout flares requiring treatment within 4 weeks
prior to or during screening.
3. Major surgery within 3 months prior to the first administration.
4. History of malignant tumors within 6 months prior to screening.
5. Subjects within the last 3 months have: myocardial infarction, angina,
percutaneous transluminal coronary angioplasty, coronary artery
bypass grafting, cerebral infarction, cerebral hemorrhage,
subarachnoid hemorrhage, or transient ischemia attack.
6. Subjects who are on other urate-lowering medication (allopurinol,
febuxostat, probenecid and benzbromarone) and cannot stop during the
study periods included in the run-in phase.
7. Subject with underlying medical conditions requiring changes or
introduction of drugs that have the potential impact on the serum uric
acid levels (e.g., salicylic acids, diuretics, angiotensin receptor
blockers, etc.) within at least 1 month prior the screening phase.
8. History of gastrointestinal (GI) surgery, including gastric sleeve,
colostomy/enterostomy, Roux-en-Y or gastric banding (unless gastric
band removed for a minimum of 12 months prior to screening.
9. History of GI diseases, including gastrointestinal bleeding moderate to
severe gastrointestinal dysfunction, moderate to severe chronic
constipation for a minimum of 3 months prior to screening, or newly
diagnosed peptic or duodenal ulcer diseases within 4 weeks prior to
screening.
10. Chronic use of parenteral nutrition including manganese within 3
months prior to screening.
11. Subjects who have the history of manganese toxicity or excessive
exposure to manganese (i.e., having worked in a mine, foundry,
smelter, dry cell battery manufacturing facility) within 2 months prior
to screening.
12. Inability to swallow oral medications.
13. Received treatment with or exposure to an investigational drug or
device within 30 days of signing informed consent.
14. Subjects with one of positive results of HIV virus, or positive hepatitis
B virus surface antigen (HBsAg) and the number of copies of hepatitis
B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500
copies, or the lower limit of the positive detection value of the study
site) at screening, or HBsAg (-), hepatitis B core antibody (HBcAb)
(+) and the number of copies of HBV DNA ≥ 500 IU/mL (or 2500
copies, or the lower limit of the positive detection value of the study
site) after treatment of HBV infection, or positive hepatitis C antibody
(HCV-Ab), and hepatitis C virus (HCV) ribonucleic acid (RNA)
≥upper limit of normal (ULN) of the study site during screening phase.
The Estimated Number of Participants
-
Taiwan
15 participants
-
Global
60 participants
