Phase Ia Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Preliminary Pharmacodynamics, and Immunogenicity of Single-dose JYB1904 in Healthy Chinese Subjects
Overview
- Phase
- Phase 1
- Intervention
- JYB1904 Placebo
- Conditions
- Healthy
- Sponsor
- Jemincare
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Adverse events (AEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
JYB1904/JYB1904 Placebo
single-dose; subcutaneous injection in the deltoid region of the upper arm.
Intervention: JYB1904 Placebo
Omalizumab
single-dose; subcutaneous injection in the deltoid region of the upper arm.
Intervention: Omalizumab
JYB1904/JYB1904 Placebo
single-dose; subcutaneous injection in the deltoid region of the upper arm.
Intervention: JYB1904
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: Baseline through 168 days post-dose
Incidence and features of AEs assessed by CTCAE v5.0
Secondary Outcomes
- Serum concentrations of total/free IgE(Baseline through 168 days post-dose)
- Serum concentrations of JYB1904 and Omalizumab(Baseline through 168 days post-dose)
- Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)(Baseline through 168 days post-dose)