Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05541627
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-10
First Post:
2022-09-13
Brief Title:
A Study to Evaluate AB-1001 Striatal Administration in Adults With Early Manifest Huntingtons Disease
Sponsor:
Brainvectis a subsidiary of Asklepios BioPharmaceutical Inc AskBio
Organization:
Asklepios Biopharmaceutical Inc
Study Overview
Official Title:
An Open-Label Phase III Dose Finding Study to Evaluate the Safety Tolerability and Preliminary Efficacy of Striatal Administration of AB-1001 in Adult Subjects With Early Manifest Huntingtons Disease HD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
A Phase III Dose-Finding Study to Evaluate Striatal Administration of AB-1001 previously BV-101 in Adults with Early Manifest Huntingtons Disease
Detailed Description:
This is a Phase III first-in-human open-label study to evaluate the safety tolerability and preliminary efficacy signals in subjects with early manifest HD following treatment with one-time intracerebral bilateral injections of AB-1001 within the striatum caudate and putamen
This study consists of 2 parts Dose-Finding Part and Expansion Part each part consists of 3 phases Screening Phase 8 weeks with extension to 12 weeks to accommodate scheduling if needed Treatment and Initial Follow-Up Phase 52 weeks and Long-Term Follow-Up Phase 4 years In the Dose-Finding Part 2 dose titers will be tested in 3-6 subjects in each cohort Once a dose is selected based on Dose-Limiting Toxicities an additional 6 subjects will be enrolled into the Dose Expansion Part
This study consists of 2 parts Dose-Finding Part and Expansion Part each part consists of 3 phases Screening Phase 8 weeks with extension to 12 weeks to accommodate scheduling if needed Treatment and Initial Follow-Up Phase 52 weeks and Long-Term Follow-Up Phase 4 years In the Dose-Finding Part 2 dose titers will be tested in 3-6 subjects in each cohort Once a dose is selected based on Dose-Limiting Toxicities an additional 6 subjects will be enrolled into the Dose Expansion Part
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