drugset / Trial / NCT06302374
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects.
Timeline
- Start
- 2023-03-04
- Primary completion
- 2023-11-01
- Completion
- 2024-02-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GR2001 | Unknown | 0.01 mg/kg | Intramuscular |
| Subject | GR2001 | Unknown | 0.02 mg/kg | Intramuscular |
| Subject | GR2001 | Unknown | 0.05 mg/kg | Intramuscular |
| Subject | GR2001 | Unknown | 0.1 mg/kg | Intramuscular |
| Subject | GR2001 | Unknown | 0.2 mg/kg | Intramuscular |
| Subject | human tetanus immunoglobulin | Protein / enzyme biologic | 250 iu | Intramuscular |
| Background | tetanus toxoid | Vaccine | — | Intramuscular |