NCT05449535

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Jemincare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JYB1904	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.
DRUG	Omalizumab	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.
DRUG	JYB1904 Placebo	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.

Timeline

• Start date: 2022-05-07
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2022-07-08
• Last updated: 2023-06-27

Locations

1 site across 1 country: China