drugset / Trial / NCT05832073
Safety, Pharmacokinetics, and Pharmacodynamic Testing of Rabies mAb CBB 1
Phase 0
Unknown
152 enrolled
Changchun BCHT Biotechnology Co.
Anning City First People's Hospital · collabBeijing Contreke Statistical Technology Co., LTD · collabMilitary Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD · collabThe First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults
Timeline
- Start
- 2023-04-30
- Primary completion
- 2023-12-30
- Completion
- 2024-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CBB 1 | Monoclonal antibody | 1.25 mg | Intramuscular |
| Comparator | Rabies Human Immunoglobulin (HRIG) | Unknown | 200 iu | Intramuscular |
| Background | Lyophilized rabies vaccine for human use (Vero cells) | Vaccine | — | — |