NCT06635798 A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
| NCT ID | NCT06635798 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. |
| Condition | Tetanus |
| Study Type | INTERVENTIONAL |
| Enrollment | 582 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2024-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 582 participants in total. It began in 2024-09-03 with a primary completion date of 2024-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
Eligibility Criteria
Inclusion Criteria: 1. Chinese male or female adults aged ≥ 18 years； 2. Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries); 3. Participants who provide signed written informed consent form. Exclusion Criteria: 1. Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions； 2. Suspect or diagnosed as tetanus; 3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies； 4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; 5. Females who are pregnant or with pregnancy test positive.
Contact & Investigator
Chuanlin Wang, MD
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06635798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tetanus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06635798 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 582 participants.
Is NCT06635798 currently recruiting?
Yes, NCT06635798 is actively recruiting participants. Contact the research team at wangchuanlinvip@163.com for enrollment information.
Where is the NCT06635798 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06635798 clinical trial?
NCT06635798 is sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. The principal investigator is Chuanlin Wang, MD at Peking University People's Hospital. The trial plans to enroll 582 participants.