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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449535
• Other study ID #: JY20210115-Ia
• Secondary ID: CTR20220973
• Status: Completed
• Phase: Phase 1
• Start date: May 7, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: June 2023
• Source: Jemincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Shulan (Hangzhou) Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Incidence and features of AEs assessed by CTCAE v5.0	Baseline through 168 days post-dose
Secondary	Serum concentrations of JYB1904 and Omalizumab	Serum JYB1904 and Omalizumab assessed by pre-specified methods, and related pharmacokinetic parameters analysis	Baseline through 168 days post-dose
Secondary	Serum concentrations of total/free IgE	Serum total/free IgE assessed by a pre-specified method, and related pharmacodynamic parameters analysis	Baseline through 168 days post-dose
Secondary	Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)	Serum ADA and Nab assessed by pre-specified methods, and related immunogenic features analysis	Baseline through 168 days post-dose