The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects
Summary
This randomized, open-label, three-period, three-treatment crossover Phase I clinical trial is designed to evaluate the pharmacokinetic profile of QLC1101 capsules administered as a single oral dose under fasting conditions, following a high-fat meal, and following a low-fat meal in healthy adult subjects. The study will further characterize the food effect on QLC1101 pharmacokinetics. A total of 18 eligible subjects will be enrolled and randomized into three treatment sequences (A, B, C) using a balanced crossover design, with 6 subjects per sequence. The study comprises three treatment periods separated by appropriate washout intervals. In each period, subjects will receive a single dose of QLC1101 under one of three distinct dietary conditions according to their assigned sequence. Following completion of the first treatment period and a washout phase, subjects will crossover to the next dietary condition in the subsequent period, with this process repeating through all three study periods.
Timeline
- Start
- 2025-06
- Primary completion
- 2025-08
- Completion
- 2025-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QLC1101 | Small molecule | — | Oral |
Indications
No indication recorded.