Clinical Trial

A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants

Completed Phase 1
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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. 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.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-13
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-10
Trial Details
NCT Number NCT07347548
Lead Sponsor Grünenthal GmbH
Conditions Duchenne Muscular Dystrophy (DMD)
Enrollment 24 participants
Start Date 2026-01-06
Primary Completion 2026-06-09 (estimated)
Study Completion 2026-06-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-12