NCT07190716

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Single Ascending Dose
• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	GR2301 injection	IL15 monoclonal antibody

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: China