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New IBD drug candidate INT-210 begins first human safety tests

NCT ID NCT07616791

Knowledge-focused Sponsor: Innatus Therapeutics (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial tested the safety and tolerability of INT-210 capsules in 86 healthy adults aged 18-45. Participants received single or multiple doses of the drug or a placebo, and researchers monitored side effects and how the drug moves through the body. The study also looked at whether food affects drug absorption. This is an early step toward possibly developing a treatment for inflammatory bowel disease (IBD).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INT-210 capsule
What this could lead to
If successful, this early safety study could pave the way for future trials testing INT-210 as a treatment for inflammatory bowel disease.
What could go wrong
This is a very early Phase 1 trial in healthy people, not patients. It only tests safety and dosing, not whether the drug works for IBD. Many drugs fail in later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

86 people

The number who actually took part.

Started

Sep 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female healthy voluteers * Aged 18-45 years(inclusive), * In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose. Exclusion Criteria: * Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception. * Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia. * Positive screening for HIV, Hepatitis B/C or syphilis; * Recent subject in another clinical trial; * Recent major surgery, or significant blood loss.

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBD (inflammatory bowel disease)

Contacts and locations

Locations

  • Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.