Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079736
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-09-29
Brief Title:
A Study Of PGN-EDO51 In Participants With Duchenne Muscular Dystrophy Amenable To Exon 51-Skipping Treatment
Sponsor:
PepGen Inc
Organization:
PepGen Inc
Study Overview
Official Title:
A Phase 2 Open-Label Multiple Ascending Dose Study of PGN-EDO51 With a Long-Term Extension in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment CONNECT1-EDO51
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECT1-EDO51
Brief Summary:
The primary purpose of the MAD period is to evaluate the safety and tolerability of multiple ascending intravenous IV doses of PGN-EDO51 administered to participants with Duchenne muscular dystrophy DMD The primary purpose of the LTE period is to evaluate the long-term safety and tolerability of PGN-EDO51 in participants who have completed the MAD period
The study consists of 3 periods A Screening Period up to 45 days a Treatment and Observation Period 16 weeks and an Extension Period 108 weeks
The study consists of 3 periods A Screening Period up to 45 days a Treatment and Observation Period 16 weeks and an Extension Period 108 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None