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NCT03362502 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03362502 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 23 participants.
The verdict
NCT03362502, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with Duchenne muscular dystrophy (DMD). Other objectives include measurement of dystrophin expression and distribution, and assessments of muscle strength, quality, and function. A total of approximately 22 subjects will receive PF-06939926, and these will include both ambulatory and non-ambulatory subjects. Up to 13 subjects may be included in a cohort that includes the concomitant medication, sirolimus. In order to mitigate unanticipated risks to subject safety, enrollment will be staggered within and between two planned dose-levels and will include a formal review by an external data monitoring committee (E-DMC) prior to dose progression.
Interventions
- GENETIC PF-06939926
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03362502
The ClinicalTrials.gov registry entry for NCT03362502 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PF-06939926 is the first listed.
NCT03362502 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03362502 about?
NCT03362502 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy". This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with Duchenne muscular dystrophy (DMD). Other objectives include measurement of...
What is the current status of trial NCT03362502?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-01-23. Estimated completion is 2025-07-28.
What interventions are being tested in trial NCT03362502?
The interventions under investigation include: PF-06939926 (GENETIC).
Who is sponsoring clinical trial NCT03362502?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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