A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult

Not Applicable

Recruiting

• Conditions: Health Adult Subjects
• Interventions: Biological: GR2303 injection; Biological: Placebo

• Registration Number: NCT07199270
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Brief Summary

he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups

Detailed Description

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.

After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-18
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Primary Completion: 2026-09-18
• Study Completion: 2026-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Healthy adult subjects
2. Signed informed consent

Exclusion Criteria

1. History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
2. Prior use of drug targeting TNF-like cytokine 1A
3. history of malignant tumor
4. psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
group 1	GR2303 injection	single dose
group 1	Placebo	single dose
group 2	GR2303 injection	single dose
group 3	GR2303 injection	single dose
group 3	Placebo	single dose
group 4	Placebo	single dose
group 2	Placebo	single dose
group 6	Placebo	multiple dose
group 7	Placebo	multiple dose
group 4	GR2303 injection	single dose
group 5	GR2303 injection	single dose
group 5	Placebo	single dose
group 6	GR2303 injection	multiple dose
group 7	GR2303 injection	multiple dose
group 8	GR2303 injection	multiple dose
group 8	Placebo	multiple dose

Primary Outcome Measures

Name	Time	Method
Adverse events	16 weeks

Secondary Outcome Measures

Name	Time	Method
t 1/2	16 weeks
Cmax	16 weeks
Tmax	16 weeks
ADA	16 weeks

Trial Locations

Locations (1)

Beijing Friendship hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China