The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers

Phase 1

Completed

• Conditions: Asthma
• Interventions: Biological: GR2002 injection; Biological: Placebo

• Registration Number: NCT05954611
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Brief Summary

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

Detailed Description

This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Study Timeline

• Study First Submitted: 2023-05-26
• Study Start: 2023-06-16
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-20
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion Criteria

• 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GR2002 injection	GR2002 injection	GR2002 subcutaneous injection
placebo	Placebo	placebo subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AE)	85 days	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	85 days	Peak Plasma concentration (Cmax)
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	85 days	Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)	85 days	Time to reach peak concentration (Tmax)
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration	85 days	Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China