drugset / Trial / NCT04213196
Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
Phase 1
Completed
66 enrolled
Sichuan Haisco Pharmaceutical Group Co., Ltd
Second Affiliated Hospital, School of Medicine, Zhejiang University · collab
RandomizedParallel-groupDouble-blindOther
Summary
This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
Timeline
- Start
- 2020-01-09
- Primary completion
- 2020-09-06
- Completion
- 2020-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HSK21542 | Peptide | 0.2 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 0.5 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 0.75 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 1 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 1.5 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 2.25 ug/kg | Intravenous |
| Subject | HSK21542 | Peptide | 3.375 ug/kg | Intravenous |
Indications
No indication recorded.