drugset / Trial / NCT07267026
A Study to Evaluate the Safety, Tolerability and PK of SK-09
RandomizedSequentialDouble-blindTreatment
Summary
This Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.
Timeline
- Start
- 2025-12-08
- Primary completion
- 2026-10-04
- Completion
- 2026-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SK-09 | Unknown | 20 mg | Oral |
| Subject | SK-09 | Unknown | 50 mg | Oral |
| Subject | SK-09 | Unknown | 100 mg | Oral |
| Subject | SK-09 | Unknown | 200 mg | Oral |
| Subject | SK-09 | Unknown | 300 mg | Oral |
| Subject | SK-09 | Unknown | 400 mg | Oral |
| Subject | SK-09 | Unknown | 500 mg | Oral |