drugset / Trial / NCT05227768
Safety and Pharmacokinetics Study of Single Ascending Doses of VV116 in Healthy Volunteers
RandomizedSequentialTriple-blindTreatment
Summary
The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK characteristics. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained. The dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.
Timeline
- Start
- 2021-11-11
- Primary completion
- 2022-01-13
- Completion
- 2022-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REMIDEVIR | Small molecule | 25 mg | Oral |
| Subject | REMIDEVIR | Small molecule | 200 mg | Oral |
| Subject | REMIDEVIR | Small molecule | 400 mg | Oral |
| Subject | REMIDEVIR | Small molecule | 800 mg | Oral |
| Subject | REMIDEVIR | Small molecule | 1200 mg | Oral |
Indications
No indication recorded.