Clinical Trials List
Protocol NumberUBP-A107-IgE
NCT Number(ClinicalTrials.gov Identfier)NCT03632291
2019-04-01 - 2020-04-01
Phase I
Recruiting2
ICD-10L50.9
Urticaria, unspecified
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
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Trial Applicant
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Sponsor
United BioPharma
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 曾涵琪 Division of Dermatology
- Lai San Wong Division of Dermatology
- 林尚宏 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Chronic Spontaneous Urticaria
Objectives
1. Evaluating the safety and tolerability of single dose UB-221 in chronic spontaneous urticaria
patients using dose-escalation design
2. Determining the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of UB-221 in
chronic spontaneous urticaria patients
Test Drug
UB-221
Active Ingredient
Anti-IgE
Dosage Form
IVT
Dosage
75 mg/ml
Endpoints
Primary Endpoints
(1) To evaluate the safety of UB-221
• Adverse event (AE)/ serious adverse event (SAE) reporting
• Assessment of infusion site reaction
• Change in vital signs
• Change in physical examinations
• Change in lab parameters, including hematology, blood biochemistry, and coagulation
• Changes in 12-lead resting electrocardiogram (ECG)
(2) To determine the tolerability and the maximal tolerated dose (MTD) of UB-221 by
dose-limiting toxicities (DLTs)
(1) To evaluate the safety of UB-221
• Adverse event (AE)/ serious adverse event (SAE) reporting
• Assessment of infusion site reaction
• Change in vital signs
• Change in physical examinations
• Change in lab parameters, including hematology, blood biochemistry, and coagulation
• Changes in 12-lead resting electrocardiogram (ECG)
(2) To determine the tolerability and the maximal tolerated dose (MTD) of UB-221 by
dose-limiting toxicities (DLTs)
Inclution Criteria
Inclusion Criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria to
be enrolled.
(1) Subjects with age between 20 to 65 years old (inclusive).
(2) Subjects who are able and willing to provide the informed consent.
(3) Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of
45 kilogram (kg) or above.
(4) Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior
to the screening visit as confirmed by investigators based on medical history.
(5) During the screening period, subjects meet UAS7 ≥ 16 and HSS7 ≥ 8 by 7-day evaluation.
(6) Subjects must have been using standard 1st line treatment with H1-antihistamine daily for at
least 2 weeks prior to the screening visit.
(7) Both male and female subjects of childbearing potential must agree to use 2 medically
accepted methods of contraception (e.g., barrier contraceptives [male condom, female
condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,
injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and
intrauterine devices) during the course of the study with their partners (excluding women who
are not of childbearing potential and men who have been sterilized).
*Female subjects who had bilateral insertion of Essure® implants (or analogous) for at least 6
months prior to the screening visit; bilateral tubal ligation, hysterectomy or bilateral
oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 2
years prior to the screening visit, are considered as non-childbearing potential by the
investigator’s judgment.
(8) Females must have a negative serum pregnancy test at the screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
In order to be eligible to participate in this study, subjects must meet all of the following criteria to
be enrolled.
(1) Subjects with age between 20 to 65 years old (inclusive).
(2) Subjects who are able and willing to provide the informed consent.
(3) Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of
45 kilogram (kg) or above.
(4) Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior
to the screening visit as confirmed by investigators based on medical history.
(5) During the screening period, subjects meet UAS7 ≥ 16 and HSS7 ≥ 8 by 7-day evaluation.
(6) Subjects must have been using standard 1st line treatment with H1-antihistamine daily for at
least 2 weeks prior to the screening visit.
(7) Both male and female subjects of childbearing potential must agree to use 2 medically
accepted methods of contraception (e.g., barrier contraceptives [male condom, female
condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,
injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and
intrauterine devices) during the course of the study with their partners (excluding women who
are not of childbearing potential and men who have been sterilized).
*Female subjects who had bilateral insertion of Essure® implants (or analogous) for at least 6
months prior to the screening visit; bilateral tubal ligation, hysterectomy or bilateral
oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 2
years prior to the screening visit, are considered as non-childbearing potential by the
investigator’s judgment.
(8) Females must have a negative serum pregnancy test at the screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
Exclusion Criteria
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from participation in this study.
(1) History of significant diseases (other than CSU) or major clinical conditions by the
investigator’s judgment, such as auto-immune disease or psychiatric and behavioral
conditions from which the investigator considers the subject is not suitable to participate in
this study.
(2) History of anaphylaxis to food, medications, or other causes.
(3) History of severe eosinophilia (eosinophil counts > 5000 /µL).
(4) History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.
(5) History of serious cardiovascular or cerebrovascular diseases by the investigator’s judgment
within 1 year prior to the screening visit.
(6) Subject who is taking beta-blocker at time of screening or is suggested to take beta-blocker
during the study period.
(7) History or presence of atopic dermatitis.
(8) Uses any of the following medications: a) systemic corticosteroids b) immunosuppressives
(such as cyclosporine). Subjects can be enrolled when they discontinued these medications
for at least 4 weeks prior to the screening visit.
(9) Subject had participated in any investigational drug trial within 60 days prior to the screening
visit.
(10) Exposure to anti-IgE monoclonal antibodies (mAb) within 12 months prior to the screening
visit.
(11) History of allergic or anaphylactic reaction to any component of the investigational product
formulation (e.g., histidine and trehalose) or other drug that in the opinion of the investigator
or medical monitor, contraindicates the subject’s participation.
(12) Subject has a history of drug abuse or heavy drinking. Heavy drinking is defined as drinking
5 glasses of drinks or more (e.g. ≥ 60 ounces/1700 mL of regular beer; 25 ounces/700 mL of
wine; 7.5 ounces/213 mL of distilled spirits) in the same occasion for 5 or more days within
30 days prior to the screening visit.
(13) Subjects with confirmed abnormal liver function test values (aspartate transaminase [AST]
and alanine transaminase [ALT]) during the screening period that are ≥ 1.5 times the upper
limit of normal (ULN).
(14) Electrocardiogram (ECG) abnormalities of clinical significance as judged by the
investigators.
(15) Confirmed HIV Infection. Positive HIV test result(s) by a current HIV screening assay.
(16) History of untreated parasitic/helminthic infection within 6 months prior to the screening
visit.
(17) Known history of prior infusion-related reaction to mAb administration.
(18) Women who are pregnant, breastfeeding, or lactating.
(19) Subject had blood donation over 250 mL within 90 days prior to the screening visit; subjects
who plan to donate blood or plan to continue blood donation during the study period.
(20) Subjects who had vaccination within 4 weeks prior to the screening visit.
Subjects who meet any of the following criteria will be excluded from participation in this study.
(1) History of significant diseases (other than CSU) or major clinical conditions by the
investigator’s judgment, such as auto-immune disease or psychiatric and behavioral
conditions from which the investigator considers the subject is not suitable to participate in
this study.
(2) History of anaphylaxis to food, medications, or other causes.
(3) History of severe eosinophilia (eosinophil counts > 5000 /µL).
(4) History of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.
(5) History of serious cardiovascular or cerebrovascular diseases by the investigator’s judgment
within 1 year prior to the screening visit.
(6) Subject who is taking beta-blocker at time of screening or is suggested to take beta-blocker
during the study period.
(7) History or presence of atopic dermatitis.
(8) Uses any of the following medications: a) systemic corticosteroids b) immunosuppressives
(such as cyclosporine). Subjects can be enrolled when they discontinued these medications
for at least 4 weeks prior to the screening visit.
(9) Subject had participated in any investigational drug trial within 60 days prior to the screening
visit.
(10) Exposure to anti-IgE monoclonal antibodies (mAb) within 12 months prior to the screening
visit.
(11) History of allergic or anaphylactic reaction to any component of the investigational product
formulation (e.g., histidine and trehalose) or other drug that in the opinion of the investigator
or medical monitor, contraindicates the subject’s participation.
(12) Subject has a history of drug abuse or heavy drinking. Heavy drinking is defined as drinking
5 glasses of drinks or more (e.g. ≥ 60 ounces/1700 mL of regular beer; 25 ounces/700 mL of
wine; 7.5 ounces/213 mL of distilled spirits) in the same occasion for 5 or more days within
30 days prior to the screening visit.
(13) Subjects with confirmed abnormal liver function test values (aspartate transaminase [AST]
and alanine transaminase [ALT]) during the screening period that are ≥ 1.5 times the upper
limit of normal (ULN).
(14) Electrocardiogram (ECG) abnormalities of clinical significance as judged by the
investigators.
(15) Confirmed HIV Infection. Positive HIV test result(s) by a current HIV screening assay.
(16) History of untreated parasitic/helminthic infection within 6 months prior to the screening
visit.
(17) Known history of prior infusion-related reaction to mAb administration.
(18) Women who are pregnant, breastfeeding, or lactating.
(19) Subject had blood donation over 250 mL within 90 days prior to the screening visit; subjects
who plan to donate blood or plan to continue blood donation during the study period.
(20) Subjects who had vaccination within 4 weeks prior to the screening visit.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
