Healthy
Conditions
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.
Interventions
DRUGJYB1904
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.
DRUGOmalizumab
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.
DRUGJYB1904 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.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
JYB1904/JYB1904 Placebo Arm: double-blind (participant and investigator); Omalizumab Arm: non-blind.
Intervention model description
JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Baseline through 168 days post-dose | Incidence and features of AEs assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
China
Outcome results
None listed