drugset / Trial / NCT07616791
A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)
RandomizedParallel-groupTriple-blindTreatment
Summary
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers. Primary Objectives: ● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers, Secondary Objectives: * To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers; * To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers; * To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
Timeline
- Start
- 2025-09-04
- Primary completion
- 2026-01-06
- Completion
- 2026-01-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INT-210 | Unknown | 50 mg | Oral |
| Subject | INT-210 | Unknown | 100 mg | Oral |
| Subject | INT-210 | Unknown | 200 mg | Oral |
| Subject | INT-210 | Unknown | 400 mg | Oral |
| Subject | INT-210 | Unknown | 600 mg | Oral |
| Subject | INT-210 | Unknown | 800 mg | Oral |