NCT06469853

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of MBF-015 in Huntington's Disease Patients

A Phase IIa, Open Label, Single Centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Orally Dosed MBF-015 in Huntington's Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medibiofarma S.L. · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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 Huntington's 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 Huntington's 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.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	MBF-015 16 mg oral capsules	MBF-015 oral capsules HDAC inhibitor

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2024-06-24
• Last updated: 2025-03-03

Locations

1 site across 1 country: Spain