At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
SRP-4045 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study Followed by an Open-Label Safety and Efficacy Evaluation of SRP-4045 in Advanced-Stage Patients With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping
In Brief
A Phase 1 clinical trial evaluating SRP-4045 and Placebo for Duchenne Muscular Dystrophy. Completed, enrolled 12 participants across 3 sites.
Detailed Summary
This is a first-in-human dose-titration and open-label extension study to assess safety, tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 45 skipping.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2015
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 21, 2015
Enrollment StartOct 8, 2015
Primary CompletionOct 3, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.9 years ago
Interventions
SRP-4045drug
SRP-4045 solution for IV infusion.
Placebodrug
SRP-4045 placebo-matching solution for IV infusion.