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Healthy men help test new Drug's safety

NCT ID NCT07450521

Knowledge-focused Sponsor: Mediar Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and how the body processes an experimental drug called MTX-463 in 8 healthy adult males. Participants received either the drug or a placebo by injection. The goal was to check for side effects and measure drug levels in the blood, not to treat any disease.

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

8 people

The number who actually took part.

Started

Feb 2026

Finished

Mar 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 60 years

Sex

Male participants only

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: * Males aged 18 to 60 years, inclusive * Able to understand the study and provide signed, written informed consent * Able to read and understand the language of the informed consent form and other study-related materials * Willing and able to complete all protocol-required study visits and procedures * Male participants with female partners of childbearing potential must use condoms during the treatment and until 125 days after the dose of study drug. Exclusion Criteria: * Any history of clinically significant lung disease as determined by the Investigator * Any other concurrent active medical condition determined clinically significant by the Investigator * Any current skin conditions or rashes that involve the planned area of injection * Body mass index (BMI) \>30 kg/m2 * Use of any systemic immunosuppressant medications, medications to treat diabetes, antipsychotics, anticoagulants, or other medications within 90 days of Screening * Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening * Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) * Planning to contribute to pregnancy during the study and up to 125 days after the participant's dose of study drug * History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening * Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety * Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic

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As listed by the trial registrant

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

Healthy adult male

Contacts and locations

Locations

  • Icon Slc Cru

    Salt Lake City, Utah, 84124, United States

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