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A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Summary
This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-10-10
Completion Date
2026-05-30
Last Updated
2025-09-24
Healthy Volunteers
Yes
Conditions
Interventions
GR2301 injection
IL15 monoclonal antibody
Locations (1)
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China