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

NCT07616791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-06-01

No results posted yet for this study

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;

Conditions

  • IBD (Inflammatory Bowel Disease)

Interventions

DRUG

INT-210 Capsule

400 mg INT-210; Oral administration

DRUG

INT-210 Capsule

Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration

DRUG

INT-210 Capsule

Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration

DRUG

INT-210 Placebo

INT-210 Placebo BID

Sponsors & Collaborators

  • Innatus Therapeutics (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2026-01-06
Completion
2026-01-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616791 on ClinicalTrials.gov