Clinical Trial

A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)

Study acronym: INT-210-I101
Completed Phase 1
View on ClinicalTrials.gov →
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;
Trial Details
NCT Number NCT07616791
Lead Sponsor Innatus Therapeutics (Shanghai) Co., Ltd.
Conditions IBD (Inflammatory Bowel Disease)
Enrollment 86 participants
Start Date 2025-09-04
Primary Completion 2026-01-06 (estimated)
Study Completion 2026-01-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-01