drugset / Trial / NCT06360250
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Fully Human Anti-tetanus Toxin Monoclonal Antibody A82 / B86 Injection Combination Formulation
Phase 0
Unknown
190 enrolled
Changchun BCHT Biotechnology Co.
Anning City First People's Hospital · collabThe First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the full human anti-tetanus toxin monoclonal antibody A82 / B86 injection combination formulation
Timeline
- Start
- 2024-04-10
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | A82 | Monoclonal antibody | 1.25 mg | Intramuscular |
| Subject | B86 | Monoclonal antibody | 1.25 mg | Intramuscular |
| Comparator | Tetanus human immunoglobulin | Protein / enzyme biologic | — | — |
| Background | Adsorbed tetanus vaccine | Vaccine | — | — |