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A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)
Sponsor: Innatus Therapeutics (Shanghai) Co., Ltd.
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;
Official title: 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 Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2025-09-04
Completion Date
2026-01-06
Last Updated
2026-06-01
Healthy Volunteers
Yes
Conditions
Interventions
INT-210 Capsule
400 mg INT-210; Oral administration
INT-210 Capsule
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
INT-210 Capsule
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
INT-210 Placebo
INT-210 Placebo BID
Locations (1)
Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
Beijing, China