Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469853
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Study to Assess the Safety Pharmacokinetics and Pharmacodynamics of MBF-015 in Huntingtons Disease Patients
Sponsor:
Medibiofarma SL
Organization:
Medibiofarma SL
Study Overview
Official Title:
A Phase IIa Open Label Single Centre Study to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of Orally Dosed MBF-015 in Huntingtons Disease Patients
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 is a Phase IIa proof of concept single center clinical trial to evaluate the safety and efficacy of daily MBF-015 oral treatment during 28 days in Huntingtons Disease patients on top of standard of care
Detailed Description:
This is a Phase 2a study to evaluate the safety tolerability and exploratory efficacy of daily oral treatment with either 16 mg or 32 mg MBF-015 during 28 days in Huntingtons disease patients with cognitive impairment in order to provide reliable safety tolerability and PK data that will guide drug dose and therapeutic regimen choices in subsequent clinical studies
The study design is a single-center open-label group consisting of two cohorts one dosed with 16 mg MBF-015 daily for 28 days and one dosed with 32 mg MBF-015 daily for 28 days in approximately 5 subjects per cohort without placebo control No randomisation is required
For each subject the study duration will last a total of approximately 7-9 weeks consisting of a screening period of 1-3 weeks a treatment period of 4 weeks and a follow-up period of 2 weeks
The study design is a single-center open-label group consisting of two cohorts one dosed with 16 mg MBF-015 daily for 28 days and one dosed with 32 mg MBF-015 daily for 28 days in approximately 5 subjects per cohort without placebo control No randomisation is required
For each subject the study duration will last a total of approximately 7-9 weeks consisting of a screening period of 1-3 weeks a treatment period of 4 weeks and a follow-up period of 2 weeks
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