drugset / Trial / NCT05429723
First-in-Human Study to Investigate the Safety and Tolerability and Pharmacokinetics of HS-10383
RandomizedSequentialDouble-blindTreatment
Summary
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of HS-10383 using a randomized, double blind, placebo controlled, single center study design. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be one single dose of study drug/placebo received on only one day. The total study duration for each participant will be usually no more than 10 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS-10383 | Unknown | 50 mg | Oral |
| Subject | HS-10383 | Unknown | 150 mg | Oral |
| Subject | HS-10383 | Unknown | 450 mg | Oral |
| Subject | HS-10383 | Unknown | 900 mg | Oral |