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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JYB1904; Drug: JYB1904 Placebo; Drug: Omalizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Shulan (Hangzhou) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYB1904/JYB1904 Placebo; single-dose; subcutaneous injection in the deltoid region of the upper arm.	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.; Drug: 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.
Active Comparator: Omalizumab; single-dose; subcutaneous injection in the deltoid region of the upper arm.	Drug: 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.; Other Names: Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence and features of AEs assessed by CTCAE v5.0	Baseline through 168 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Guiling Chen, MD, Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2022
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: IgE; moderate to severe persistent allergic asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: JY20210115-Ia; CTR20220973 (Registry Identifier: National Medical Products Administration of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No