Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
Study Details
Study Description
Brief Summary
This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.
The sequential dose levels (sample size) of JYB1904 are set at 75 mg(6), 150 mg(8), 300 mg(8), 450 mg(8) and 600mg(8), with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair), 150 mg(8).
Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JYB1904/JYB1904 Placebo
|
Drug: JYB1904
Dosage form: injection, solution； Usage and dosage :75 mg, 150 mg, 300 mg, 450 mg, 600 mg; single-dose; subcutaneous injection in the deltoid region of the upper arm.
Drug: JYB1904 Placebo
Dosage form: injection, solution； Usage and dosage :75 mg, 150 mg, 300 mg, 450 mg, 600 mg; single-dose; subcutaneous injection in the deltoid region of the upper arm.
|
| Active Comparator: Omalizumab
|
Drug: Omalizumab
Dosage form: injection, powder, lyophilized, for solution； Usage and dosage :150 mg; single-dose; subcutaneous injection in the deltoid region of the upper arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Adverse events (AEs) [Baseline through 168 days post-dose]
Incidence and features of AEs assessed by CTCAE v5.0
Secondary Outcome Measures
- Serum concentrations of JYB1904 and Omalizumab [Baseline through 168 days post-dose]
Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis
- Serum concentrations of total/free IgE [Baseline through 168 days post-dose]
Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis
- Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab) [Baseline through 168 days post-dose]
Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
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Healthy Chinese subjects aged 18-50 years, male or female;
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Male weight ≥50.0 kg, female weight ≥45.0 kg; and both ≤ 90 kg, body mass index (BMI) within the range of 18.0-28.0 kg/m^2;
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Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others (chest X-ray, abdomen ultrasonography, 12-lead ECG, etc.).
Exclusion Criteria:
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Surgery history within 6 months prior to screening or any surgery schedule during the study;
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Blood donation or blood loss ≥400 mL or received blood/blood products treatment within 3 months prior to screening;
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Immediate or delayed hypersensitivity history to the active ingredient or excipients of the study drugs, hypersensitive state or other allergic disease history (asthma, urticaria, eczematous dermatitis, etc.), or allergic to protein products;
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Smokers ≥10 cigarettes/day within 3 months prior to screening or cannot promise to quit smoking during the study;
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Male/female drinkers >25 g/15 g alcohol/day within 6 months prior to screening or cannot promise to quit drinking during the study, or positive breath alcohol test;
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Substance abuse history within 12 months prior to screening, or positive urine drug test;
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Received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid therapy within 5 years prior to screening;
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With clinically significant abnormalities confirmed by the investigator in cardiovascular system, respiratory system, digestive system, endocrine system (e.g. diabetes), nervous/psychiatric system, hematologic/lymphatic system (e.g. immune system deficiency), or skeletal/musculoskeletal system;
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Received any prescription/nonprescription drug, traditional Chinese medicine, vitamins or health care products within 1 month prior to screening;
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Received omalizumab or other drugs affecting IgE levels within 1 year prior to screening;
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Vaccination history within 1 month prior to screening, or any vaccination schedule during the study;
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With difficulty in venous blood collection or subcutaneous injection, or blood/syringe needle phobia;
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Last visit in previous drug clinical trial within 3 months or 5 drug half-life periods prior to screening;
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Pregnancy or lactation, or positive pregnancy test, or cannot use non-drug contraceptives confirmed by the investigator during the study, or sperm/ovum donators;
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Positive HBsAg, anti-hepatitis C virus (HCV) antibody , HIV antigen/antibody combined test, or treponema pallidum specific antibody test (TP-ELISA);
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Total serum IgE >100 IU/mL at screening;
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Acute diseases occur or receive any medication during the screening period;
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Take tobacco or alcohol, or strenuous exercise, or other conditions that may affect drug absorption, distribution, metabolism or excretion within 48 hours before drug administration and during the study;
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Other conditions unsuitable for the study confirmed by the investigator (weak state, poor compliance, etc.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shulan (Hangzhou) Hospital | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Jemincare
Investigators
- Principal Investigator: Guiling Chen, MD, Shulan Hospital of Hangzhou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JY20210115-Ia
- CTR20220973