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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05954611
Study type Interventional
Source Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Contact Yi Fang, MD
Phone 010-66583834
Email fygk7000@163.com
Status Recruiting
Phase Phase 1
Start date June 16, 2023
Completion date November 30, 2023

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