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

NCT05449535 | Completed Phase 1

• 2 other identifiers: JY20210115-IaCTR20220973
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Incidence and features of AEs assessed by CTCAE v5.0

  Baseline through 168 days post-dose

Secondary Outcomes (3)

• Serum concentrations of JYB1904 and Omalizumab

  Baseline through 168 days post-dose

• Serum concentrations of total/free IgE

  Baseline through 168 days post-dose

• Serum concentrations of anti-drug antibody (ADA) and neutralizing antibody (Nab)

  Baseline through 168 days post-dose

Study Arms (2)

JYB1904/JYB1904 Placebo

EXPERIMENTAL

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

Drug: JYB1904; Drug: JYB1904 Placebo

Omalizumab

ACTIVE COMPARATOR

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

Drug: Omalizumab

Interventions

JYB1904 DRUG

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.

JYB1904/JYB1904 Placebo

Omalizumab DRUG

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.

Also known as: Xolair

Omalizumab

JYB1904 Placebo DRUG

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.

JYB1904/JYB1904 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Guiling Chen, MD

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: JYB1904/JYB1904 Placebo Arm: double-blind (participant and investigator); Omalizumab Arm: non-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: JYB1904/JYB1904 Placebo Arm: dose escalation. Omalizumab Arm: one dose level .

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 8, 2022
• Study Start: May 7, 2022
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)