A Phase Ia Study of KMY Tablets in Healthy Subjects
Summary
This is a Phase Ia, randomized, double-blind, placebo-controlled study conducted in healthy subjects. The study plans to enroll a total of 120 participants, with both males and females included in all parts. The trial consists of three distinct parts: Part A (Single-Ascending Dose, SAD): A total of 72 subjects will be enrolled to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of KMY Tablets. Part B (Multiple-Ascending Dose, MAD): A total of 36 subjects will be enrolled to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of KMY Tablets. Part C (Food-Effect): A total of 12 subjects will be enrolled to assess the impact of a high-fat, high-calorie meal on the pharmacokinetic profile of KMY Tablets. The primary objectives are to evaluate the safety and tolerability of single and multiple doses of KMY Tablets and to assess the food effect on its pharmacokinetics. The secondary objectives include characterizing the single- and multiple-dose pharmacokinetics, investigating the drug's metabolism and excretion, and evaluating the safety and tolerability in the fed state. Exploratory pharmacodynamic parameters may also be investigated.
Timeline
- Start
- 2025-12-15
- Primary completion
- 2026-11-07
- Completion
- 2026-11-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KMY | Unknown | 2 mg | Oral |
| Subject | KMY | Unknown | 6 mg | Oral |
| Subject | KMY | Unknown | 10 mg | Oral |
| Subject | KMY | Unknown | 20 mg | Oral |
| Subject | KMY | Unknown | 40 mg | Oral |
| Subject | KMY | Unknown | 60 mg | Oral |
| Subject | KMY | Unknown | 80 mg | Oral |
| Subject | KMY | Unknown | 90 mg | Oral |
| Subject | KMY | Unknown | 120 mg | Oral |
Indications
No indication recorded.