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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07199270

Enrollment

Registered

2025-09-30

Start date

2025-09-18

Completion date

2026-12-16

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Adult Subjects

Keywords

Inflamatory bowel disease, phase 1, GR2303

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.

Interventions

BIOLOGICALGR2303 injection

single dose

BIOLOGICALPlacebo

single dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Adverse events	16 weeks

Secondary

Measure	Time frame
Cmax	16 weeks
Tmax	16 weeks
t 1/2	16 weeks
ADA	16 weeks

Countries

China

Contacts

Primary ContactNian

nianhanli@genrixbio.com021-50805989-08324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026