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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JYB1904; Drug: Omalizumab; Drug: JYB1904 Placebo

• Registration Number: NCT05449535
• Lead Sponsor: Jemincare

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.

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 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.

Study Timeline

• Study Start: 2022-05-07
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Primary Completion: 2023-01-10
• Study Completion: 2023-01-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
2. Healthy Chinese subjects aged 18-50 years, male or female;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.

Exclusion Criteria

1. Surgery history within 6 months prior to screening or any surgery schedule during the study;
2. Last visit in previous drug clinical trial within 3 months prior to screening;
3. Acute diseases occur or receive any medication during the screening period;
4. Other conditions unsuitable for the study confirmed by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JYB1904/JYB1904 Placebo	JYB1904 Placebo	single-dose; subcutaneous injection in the deltoid region of the upper arm.
JYB1904/JYB1904 Placebo	JYB1904	single-dose; subcutaneous injection in the deltoid region of the upper arm.
Omalizumab	Omalizumab	single-dose; subcutaneous injection in the deltoid region of the upper arm.

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Baseline through 168 days post-dose	Incidence and features of AEs assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Shulan (Hangzhou) Hospital; 🇨🇳 Hangzhou, Zhejiang, China