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NOT YET RECRUITING
NCT07190716
PHASE1

A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.

Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

GR2301 injection

IL15 monoclonal antibody

Locations (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China