Clinical trial

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

Name

JY20210115-Ia

Description

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.

Trial arms

Trial start

2022-05-07

Estimated PCD

2023-01-10

Trial end

2023-01-10

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

JYB1904/JYB1904 Placebo

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.

Arms:

Omalizumab

Other names:

Xolair

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.

Arms:

JYB1904/JYB1904 Placebo

Size

Primary endpoint

Adverse events (AEs)

Baseline through 168 days post-dose

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'JYB1904/JYB1904 Placebo Arm: double-blind (participant and investigator); Omalizumab Arm: non-blind.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

Updated at

2023-06-27

1 organization

2 products

1 indication

Product

Indication

Product

Organization