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

Sponsor
Jemincare
Study ID
NCT05449535
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • JYB1904 — DRUG
    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.
  • Omalizumab — DRUG
    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.
  • JYB1904 Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 7, 2022
Status verified
Jun 2023
Primary completion
Jan 10, 2023
Completion
Jan 10, 2023

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JYB1904/JYB1904 Placebo
    single-dose; subcutaneous injection in the deltoid region of the upper arm.
  • Active Comparator: Omalizumab
    single-dose; subcutaneous injection in the deltoid region of the upper arm.

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Baseline through 168 days post-dose ]

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