drugset / Trial / NCT07262346
The Phase Ⅰd Clinical Trial of Hydronidone Capsules
Phase 1
Not yet recruiting
138 enrolled
Beijing Continent Pharmaceutical Co, Ltd.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.
Timeline
- Start
- 2025-12-05
- Primary completion
- 2026-05-05
- Completion
- 2026-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydronidone | Small molecule | 120 mg | Oral |
| Subject | Hydronidone | Small molecule | 180 mg | Oral |
| Subject | Hydronidone | Small molecule | 240 mg | Oral |
| Subject | Hydronidone | Small molecule | 300 mg | Oral |
| Subject | Hydronidone | Small molecule | 360 mg | Oral |
| Subject | Hydronidone | Small molecule | 420 mg | Oral |