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NCT Number: NCT07199270

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

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

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Key information

Conditions

Health Adult Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Friendship hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Professor Dong

CONTACT

[email protected]

010-63139003

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult subjects
  • Signed informed consent

Exclusion criteria

  • 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)

Treatment and study plan

GR2303 injection

Biological

single dose

Placebo

Biological

single dose

Primary outcomes

  1. Adverse events

    Time frame: 16 weeks

Secondary outcomes

  1. Cmax

    Time frame: 16 weeks

  2. Tmax

    Time frame: 16 weeks

  3. t 1/2

    Time frame: 16 weeks

  4. ADA

    Time frame: 16 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Nian

CONTACT

[email protected]

021-50805989-08324

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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