Evaluating a new injection for respiratory syncytial virus in healthy adults
A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102
This study is testing a new injection for respiratory syncytial virus in healthy adults to see if it's safe and how well it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06313697 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, immunogenicity, and pharmacokinetics of the GR2102 injection in healthy adult participants. It employs a randomized, double-blind, placebo-controlled design, where subjects are assigned to receive either the GR2102 injection or a placebo. Participants will be enrolled in sequential groups, with safety observations conducted before moving to the next group. The study includes a follow-up period of at least 150 days post-dosing to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult individuals who meet the inclusion criteria.
Not a fit: Patients with a history of respiratory infections or prior RSV vaccinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new preventive treatment for respiratory syncytial virus infections.
How similar studies have performed: While there have been studies on RSV treatments, the specific approach of GR2102 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy adult subjects 2. Signed informed consent Exclusion Criteria: 1. Signs and symptoms of upper respiratory tract infection prior to randomization 2. Prior use of RSV vaccine or RSV antibody-based medications 3. history of malignant tumor
Where this trial is running
Jinan, Shandong
- The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: wei zhao, PHD — Shandong First Medical University
- Study coordinator: wei zhao, PHD
- Email: zhao4wei@hotmail.com
- Phone: 15131190710
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.