Duchenne Muscular Dystrophy (DMD)Phase 1NCT07347548
A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants
A Phase 1 study testing GRT6019 in people with Duchenne Muscular Dystrophy (DMD), run by Grünenthal GmbH at 1 site in France.
Trial summary
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- GRT6019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2026to 9 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- 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.
- 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.
- Participant must sign the informed consent form before any trial-related assessments.
- 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:
- 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
- Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s)
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants.
This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts.
For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
Read the detailed description
There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- GRT6019
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT6019Drug
Multiple dose (MD)
| Study group | Role | What they receive |
|---|---|---|
| GRT6019: Cohort 1 | Experimental | 4 weeks dosing with GRT6019 low dose once a day [QD] Receives: Drug: GRT6019 |
| GRT6019: Cohort 2 | Experimental | 4 weeks dosing with GRT6019 medium dose once a day [QD] Receives: Drug: GRT6019 |
| GRT6019: Cohort 3 | Experimental | 4 weeks dosing with GRT6019 higher dose once a day [QD] Receives: Drug: GRT6019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Measured: Through study completion, an average of 4 Weeks
Number of participants with Serious Adverse Events (SAEs)
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Measured: Through study completion, an average of 4 Weeks
Number of participants with AEs leading to discontinuation
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Measured: Through study completion, an average of 4 Weeks
Number of participants with AEs related to investigational medicinal product [IMP]
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Measured: Through study completion, an average of 4 Weeks
Secondary outcomes (2)
Area under the concentration-time curve over the dosing interval (AUCtau)
Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment
Measured: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Maximum observed concentration (Cmax)
Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment
Measured: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start6 Jan 2026
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cohorts 1 and 2 will be dosed in parallel, followed by Cohort 3 sequentially
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347548
- Sponsor's protocol ID
- HP6019-07
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07347548
- Acronym / sponsor ID
- HP6019-07
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants.
This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts.
For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.
Detailed description
There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cohorts 1 and 2 will be dosed in parallel, followed by Cohort 3 sequentially
| Arm | Type | Receives |
|---|---|---|
| GRT6019: Cohort 1 | Experimental | Drug: GRT60194 weeks dosing with GRT6019 low dose once a day [QD] |
| GRT6019: Cohort 2 | Experimental | Drug: GRT60194 weeks dosing with GRT6019 medium dose once a day [QD] |
| GRT6019: Cohort 3 | Experimental | Drug: GRT60194 weeks dosing with GRT6019 higher dose once a day [QD] |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT6019Multiple dose (MD) | Drug | GRT6019: Cohort 1, GRT6019: Cohort 2, GRT6019: Cohort 3 |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with AEs leading to discontinuation
Time frame: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
Number of participants with AEs related to investigational medicinal product [IMP]
Time frame: Through study completion, an average of 4 Weeks
Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment
2 secondary outcomes
Area under the concentration-time curve over the dosing interval (AUCtau)
Time frame: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Maximum observed concentration (Cmax)
Time frame: Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Clinical trial transparency at GrünenthalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRT6019 in people with Duchenne Muscular Dystrophy (DMD), run by Grünenthal GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Through study completion, an average of 4 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.