drugset / Trial / NCT04404790
Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a phase 1, dose-escalation, and multidose study, aiming to investigate the tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is divided into 2 intravenous single groups and 3 continuous administration groups. The dose of Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.
Timeline
- Start
- 2020-09
- Primary completion
- 2021-03
- Completion
- 2021-05
Outcome
Outcome not reported
Stopped: “Optimization of protocol”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anfibatide | Protein / enzyme biologic | 0.002 iu/kg | Intravenous |
| Subject | Anfibatide | Protein / enzyme biologic | 0.004 iu/kg | Intravenous |
| Subject | Anfibatide | Protein / enzyme biologic | 0.008 iu/kg | Intravenous |
| Subject | Anfibatide | Protein / enzyme biologic | 0.0833333 iu/kg | Intravenous |
| Subject | Anfibatide | Protein / enzyme biologic | 0.116667 iu/kg | Intravenous |
Indications
No indication recorded.