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New drug ME3241 enters first human safety tests

NCT ID NCT07422207

Knowledge-focused Sponsor: Meiji Pharma USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called ME3241 in 104 healthy adults to see if it is safe and how the body handles it. Participants will receive either the drug or a placebo by infusion, and researchers will monitor for side effects and measure drug levels in the blood. The study is not looking for a treatment effect, but rather gathering essential safety data before any future disease-focused trials.

What this could mean

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

Active substance
ME3241
What could go wrong
This is a very early phase 1 trial in healthy volunteers, so it is not designed to test if ME3241 works for any disease. The drug may prove unsafe or ineffective in later studies.

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 104 people

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

Started

Mar 2026

Expected to finish

Jul 2027

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

18 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: * Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. * Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Participant must have body weight \> 45 kg at the Screening Visit. * Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m\^2 at the Screening Visit. BMI = body weight (kg)/(height \[m\])\^2. Exclusion Criteria: * Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection. * Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit. * Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study. * Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated. Other protocol defined inclusion/exclusion criteria could apply.

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As listed by the trial registrant

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

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Scientia Clinical Reserch Ltd

    RECRUITING

    Sydney, New South Wales, 2031, Australia

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