Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489511
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2020-07-21
Brief Title:
Study of STG-001 in Subjects With Stargardt Disease
Sponsor:
Stargazer Pharmaceuticals Inc
Organization:
Stargazer Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2a Study of the Safety Pharmacokinetics and Pharmacodynamics of STG-001 in Subjects With Stargardt Disease STGD1 Caused by Autosomal Recessive Mutation in ATP Binding Cassette Subfamily A Member 4 ABCA4 Gene
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter study in subjects with Stargardt disease comparing 2 doses of STG-001 with regard to safety pharmacokinetics and pharmacodynamics
Detailed Description:
This is an open-label multicenter active treatment study in approximately 12 subjects aged 18 to 55 years inclusive with STGD1 genotyped with a minimum of two ABCA4 gene mutations Treatment course of STG-001 at Dose 1 Cohort 1 or Dose 2 Cohort 2 testing doses will be administered once daily for 28 days Cohorts will run in parallel Subjects will receive their designated dose daily for 28 days and be monitored for safety measures during the dosing period and for an additional 28 days after dosing through Day 56
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