Can a new drug pair safely with a known Anti-Inflammatory? a trial investigates

NCT ID NCT07776782

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This early-stage trial is evaluating the safety and tolerability of a single dose of the investigational drug MT-201 when given alongside infliximab, an approved anti-inflammatory medication. Healthy adults aged 19 to 55 will receive the combination and be monitored for side effects, laboratory changes, and immune responses. The goal is to understand how the body handles both drugs together, which could inform future studies in people with inflammatory diseases.

What this could mean

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

Active substance
MT-201 (an investigational drug) given together with infliximab
What this could lead to
If successful, this could support further development of MT-201 as a potential treatment for inflammatory conditions.
What could go wrong
This is an early-phase study in healthy volunteers, so results may not predict effects in patients. Side effects or immune responses could occur.

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

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

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

19 to 55 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: 1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent. 2. Females must be of non-childbearing potential and must have undergone sterilization procedures, and have official documentation, at least 6 months prior to the first dose. 3. Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. 4. Good general health. 5. Able to provide written informed consent and understand and comply with the requirements of the study. Exclusion Criteria: 1. History or presence of any clinically significant organ system disease. 2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant. 3. History of alcohol or drug abuse within the past 24 months. 4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening. 5. Administration of any prescription drug within 21 days or 5 half-lives (whichever is longer) of study drug administration; or over-the-counter drug within 7 days or 5 half-lives (whichever is longer) of study drug administration. 6. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration. 7. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing. 8. Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.

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As listed by the trial registrant

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

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mirador Clinical Department

    RECRUITING

    San Diego, California, 92121, United States

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