NCT06049147

Study to Assess the Safety and Tolerability of MBF-015 in Healthy Young Volunteers

Randomized, Double Blind, Placebo Controlled "First-in-human" Study to Assess the Safety and Tolerability of Single Ascending Oral Doses and Multiple Oral Doses of MBF-015 in Healthy Young Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Medibiofarma S.L. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young men and woman. MBF-118 is developed for the treatment of multiple sclerosis.

Detailed description

This clinical phase I trial is divided in two stages. The first stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral ascending dose to healthy young male volunteers. Up to four different rising doses will be tested (4 mg, 8 mg, 16 mg, 32 mg, 64 mg) in groups/cohorts of 8 participants. Thus, five groups/cohorts will participate. For each dose level/group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug and another one will receive placebo (subgroup 1); after at least 72h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 72h of safety and tolerability parameters assessment, a third subgroup of 3 volunteers will receive the active drug. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages. The second stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral daily dose, during 5 days to young male and female healthy volunteers. Up to four different rising dose levels will be tested (8 mg, 16 mg, 32 mg, and 64 mg) in cohorts of 8 subjects that are randomised to active treatment and placebo (6:2) and divided into three subsequent treatment blocks, as described above in the first stage. The pharmacokinetics profile of MBF-015 will be also assessed at each dose level tested of the Single ascending dose study and the multiple ascending dose study. The 64 mg SAD part will also be used to measure the product concentration in cerebrospinal fluid (CSF).

Conditions

• Safety and Pharmacokinetic

Interventions

Type	Name	Description
DRUG	MBF-015 4 mg oral capsule	MBF-015 oral capsules Histone deacetylase inhibitor
DRUG	MBF-015 16 mg oral capsule	MBF-015 oral capsules Histone deacetylase inhibitor
DRUG	Placebo	Hard gelatin capsules filled with cellulose microcrystalline

Timeline

• Start date: 2021-07-07
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Spain