Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study of GR2303 Injection in Healthy Adult Subjects to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacology
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2025-09-30
64
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of GR2303 injection in healthy adult subjects aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase 1 study aims to gather initial information on how the body processes GR2303 and its potential effects compared to placebo. The study is sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. Participants will be randomly assigned to one of several groups receiving either a single or multiple doses of GR2303 injection or placebo. Each subject will be enrolled in only one group, and dosing schedules differ between groups to evaluate different administration patterns. Both GR2303 and placebo are given by injection under controlled, blinded conditions to ensure unbiased assessment. During the study, participants will undergo safety monitoring for adverse events over a 16-week period. Researchers will also measure drug concentration peaks, time to peak concentration, half-life, and immune reactions against the drug. Subjects will complete study visits and evaluations according to the assigned dosing group, with careful observation to track tolerability and pharmacological responses throughout the trial.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult subjects
- Signed informed consent
You will not qualify if you...
- History or presence of any clinically significant organ system disease that could interfere with study objectives or safety
- Prior use of drug targeting TNF-like cytokine 1A
- History of malignant tumor
- Positive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV) infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive either a single or multiple dose of the study drug or placebo according to their assigned group.
1 baseline visit and multiple follow-up visits during treatment
Duration - Up to 16 weeks following treatment
Participants are monitored for safety, immunogenicity, and pharmacokinetics after treatment ends.
Multiple follow-up visits
Trial Site Locations
Total: 1 location
1
Beijing Friendship hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
N
Nian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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