Trials / Completed
CompletedNCT06350279
A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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 HSK39297 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK39297 | 50-600mg |
Timeline
- Start date
- 2023-12-25
- Primary completion
- 2024-08-02
- Completion
- 2024-09-29
- First posted
- 2024-04-05
- Last updated
- 2025-01-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06350279. Inclusion in this directory is not an endorsement.