RecruitingPhase 1NCT07199270

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

A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303


Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Enrollment

64 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

  • Healthy adult subjects
  • Signed informed consent

Exclusion Criteria4

  • 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.
  • Prior use of drug targeting TNF-like cytokine 1A
  • history of malignant tumor
  • psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)

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Interventions

BIOLOGICALGR2303 injection

single dose

BIOLOGICALPlacebo

single dose

BIOLOGICALGR2303 injection

multiple dose

BIOLOGICALPlacebo

multiple dose


Locations(1)

Beijing Friendship hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07199270


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