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

Jemincare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omalizumab; Drug: JYB1904 Placebo; Drug: JYB1904

Study type: Interventional

Funder types: Industry

Identifiers

NCT05449535

CTR20220973 (Registry Identifier)

JY20210115-Ia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

JYB1904/JYB1904 Placebo

Experimental group

Description:

single-dose; subcutaneous injection in the deltoid region of the upper arm.

Treatment:

Drug: JYB1904 Placebo

Drug: JYB1904

Omalizumab

Active Comparator group

Description:

single-dose; subcutaneous injection in the deltoid region of the upper arm.

Treatment:

Drug: Omalizumab