drugset / Trial / NCT06858657
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK44459 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.
Timeline
- Start
- 2024-08-17
- Primary completion
- 2024-11-18
- Completion
- 2024-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HSK44459 | Unknown | — | Oral |
Indications
No indication recorded.