drugset / Trial / NCT07266207
Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic, and Food Effects of ARD-885 Film-coated Tablets in Healthy Chinese Subjects and Patients With Rheumatoid Arthritis
RandomizedSequentialQuadruple-blindTreatment
Summary
The proposed study is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetic, and food effects of ARD-885 Film-coated Tablets in healthy subjects.The entire study includes 3 parts: a single ascending dose study, a multiple ascending dose study, and a food-effect bioavailability study in healthy subjects.
Timeline
- Start
- 2024-12-16
- Primary completion
- 2025-08-14
- Completion
- 2025-08-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARD-885 | Unknown | 5 mg | — |
| Subject | ARD-885 | Unknown | 10 mg | — |
| Subject | ARD-885 | Unknown | 25 mg | — |
| Subject | ARD-885 | Unknown | 30 mg | — |
| Subject | ARD-885 | Unknown | 50 mg | — |
| Subject | ARD-885 | Unknown | 60 mg | — |
| Subject | ARD-885 | Unknown | 100 mg | — |
| Subject | ARD-885 | Unknown | 150 mg | — |
| Subject | ARD-885 | Unknown | 200 mg | — |
| Subject | ARD-885 | Unknown | 250 mg | — |