Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467344
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-31
Brief Title:
Study to Evaluate ACDN-01 in ABCA4-related Retinopathy STELLAR
Sponsor:
Ascidian Therapeutics Inc
Organization:
Ascidian Therapeutics Inc
Study Overview
Official Title:
ACDN-01-001 Open-Label Single Ascending Dose Study to Evaluate the Safety Tolerability and Preliminary Efficacy of Subretinal ACDN-01 in Participants with ABCA4-related Retinopathy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is an open-label single ascending dose clinical trial in participants who have ABCA4-related retinopathies This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety tolerability and preliminary efficacy following a single subretinal injection of ACDN-01
Detailed Description:
This is an open-label single ascending dose study of ACDN-01 in adult participants with ABCA4-related retinopathy The study is designed to evaluate the safety tolerability and evidence of biological effect of SAD levels low medium and high of ACDN-01 when delivered subretinally
Participants will be followed on study for 2 years for the primary safety and preliminary efficacy endpoints after which they will continue in the study in a 3-year long-term follow-up period for a total study duration of 5 years
Participants will be followed on study for 2 years for the primary safety and preliminary efficacy endpoints after which they will continue in the study in a 3-year long-term follow-up period for a total study duration of 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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