Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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 five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair). Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.

Official Title
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Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: JYB1904
* Drug: Omalizumab
* Drug: JYB1904 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the study and provide written informed consent voluntarily, and comply with the requirements; Healthy Chinese subjects aged 18-50 years, male or female; Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others. Exclusion Criteria: Surgery history within 6 months prior to screening or any surgery schedule during the study; Last visit in previous drug clinical trial within 3 months prior to screening; Acute diseases occur or receive any medication during the screening period; Other conditions unsuitable for the study confirmed by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JYB1904/JYB1904 Placebo<br>single-dose; subcutaneous injection in the deltoid region of the upper arm. | Drug: JYB1904<br>* Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.<br>Drug: JYB1904 Placebo<br>* Dosage form: injection, solution； Usage and dosage matching:dose 1, dose 2, dose 3, dose 4, dose 5; single-dose; subcutaneous injection in the deltoid region of the upper arm.<br>|
| Active Comparator: Omalizumab<br>single-dose; subcutaneous injection in the deltoid region of the upper arm. | Drug: Omalizumab<br>* Dosage form: injection, powder, lyophilized, for solution； Usage and dosage matching:dose 1; single-dose; subcutaneous injection in the deltoid region of the upper arm.<br>* Other names: Xolair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence and features of AEs assessed by CTCAE v5.0 | Baseline through 168 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of JYB1904 and Omalizumab | Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis | Baseline through 168 days post-dose | 
| Serum concentrations of total/free IgE | Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis | Baseline through 168 days post-dose | 
| Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab) | Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis | Baseline through 168 days post-dose |