GR2303 injection safety and immune response in healthy adults
A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
This trial will try GR2303 injections in healthy adults to see if they are safe and how the body handles them and responds immunologically.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07199270 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 1 trial enrolls healthy adult Chinese volunteers into sequential cohorts. Within each cohort, participants are randomly assigned to receive either GR2303 injection or placebo, and each participant is enrolled in only one group. The study collects safety data, tolerability assessments, pharmacokinetic sampling, and immunogenicity testing over scheduled visits. Findings will inform dosing and further clinical development for inflammatory conditions.
Who should consider this trial
Good fit: Healthy adults who can give informed consent, pass screening exams and labs, and have no significant organ disease or prior use of TNF-like cytokine 1A–targeting drugs are eligible.
Not a fit: People with active inflammatory disease seeking therapy, a history of malignancy, positive hepatitis B/C or HIV tests, significant organ disease, or prior exposure to TNF-like cytokine 1A–targeting therapies are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, GR2303 could become a new immune-targeting treatment option for inflammatory conditions such as inflammatory bowel disease.
How similar studies have performed: Other biologics targeting related inflammatory cytokines have shown promise in later-stage trials, but GR2303 is a novel agent undergoing early human testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Beijing, Beijing Municipality
- Beijing Friendship hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Nian
- Email: nianhanli@genrixbio.com
- Phone: 021-50805989-08324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.