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New drug GRT6019 takes first step toward duchenne treatment

NCT ID NCT07347548

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 2 times

Summary

This early-phase trial tests the safety and tolerability of a new drug called GRT6019 in 24 healthy men. Participants receive multiple doses over 4 weeks and are monitored for side effects and how the drug moves through the body. The goal is to see if GRT6019 is safe enough to study further in people with Duchenne muscular dystrophy.

What this could mean

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

Active substance
GRT6019
What this could lead to
If safe, this could lead to larger trials testing GRT6019 as a potential treatment for Duchenne muscular dystrophy.
What could go wrong
This is a very early, small trial in healthy men, not patients. It only tests safety and drug levels, not whether it works for DMD. Many early-stage drugs fail to show benefit later.

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

24 people

The number who actually took part.

Started

Jan 2026

Finished

Jun 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 55 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.

Main Inclusion Criteria: 1. Participant must be male, 18 to 55 years of age (inclusive) at the time of signing the informed consent form and affiliated to the social security system. 2. Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Participant must sign the informed consent form before any trial-related assessments. 4. The participant is in good health as determined by the medical history, physical examination, 12-lead ECG, vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure \[BP\]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the exclusion criteria. The population of this clinical trial is healthy volunteer participants. Main Exclusion Criteria: 1. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, comparator, rescue medication, or any ingredients therein, or may affect the interpretation of the results, or may render the participant at high risk from treatment complications/ participation in the study unsafe 2. Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial 3. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s) 4. Regularly uses any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial 5. Concurrent enrollment in another clinical trial, unless it is an observational (non interventional) clinical trial or during the follow-up period of an interventional trial 6. Recent participation in another clinical trial with an IMP administered within 30 days before Day 1 or within 5 times the elimination half-life of the IMP, whichever is longer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Biotrial Clinical Pharmacology Unit

    Rennes, 35042, France

More trials for these conditions

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