drugset / Trial / NCT07616791

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

NCT07616791 ↗

Phase 1 Completed 86 enrolled Innatus Therapeutics (Shanghai) Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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