NCT05954611

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

A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	GR2002 injection	one single dose of GR2002 injection
BIOLOGICAL	Placebo	one single dose of placebo

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2023-07-20
• Last updated: 2024-08-22

Locations

1 site across 1 country: China