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

NCT06049147 | Completed Phase 1

• 2 other identifiers: MBF-015CT-012020-005318-16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety and Pharmacokinetic

Keywords

Histone deacetylase inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  Classification based in the Medical Dictionary for Regulatory Activities (MedDRa) Adverse Events will be qualified according to the definitions and values stated in CTCAE version 5.0

  Day 1 through Day 8

Study Arms (11)

MBF-015 4mg oral single dose

EXPERIMENTAL

Drug: MBF-015 oral single dose. MBF-015 4 mg strength hard gelatin capsules

Drug: MBF-015 4 mg oral capsule

MBF-015 8 mg oral single dose

EXPERIMENTAL

Drug: MBF-015 oral single dose. Two 4 mg strength hard gelatin capsules

Drug: MBF-015 4 mg oral capsule

MBF-015 16 mg oral single dose

EXPERIMENTAL

Drug: MBF-015 oral single dose. One 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

MBF-015 32 mg oral single dose

EXPERIMENTAL

Drug: MBF-015 oral single dose. Two 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

MBF-015 64 mg oral single dose

EXPERIMENTAL

Drug: MBF-015 oral single dose. Four 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

MBF-015 8 mg oral multiple dose

EXPERIMENTAL

Drug: MBF-015 oral single daily dose during five days. Two 4 mg strength hard gelatin capsules

Drug: MBF-015 4 mg oral capsule

MBF-015 16 mg oral multiple dose

EXPERIMENTAL

Drug: MBF-015 oral single daily dose during five days. One 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

MBF-015 32 mg oral multiple dose

EXPERIMENTAL

Drug: MBF-015 oral single daily dose during five days. Two 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

MBF-015 64 mg oral multiple dose

EXPERIMENTAL

Drug: MBF-015 oral single daily dose during five days. Four 16 mg strength hard gelatin capsules

Drug: MBF-015 16 mg oral capsule

Placebo single dose

PLACEBO COMPARATOR

Placebo Hard gelatin capsules filled with cellulose microcrystalline. One single administration

Drug: Placebo

Placebo multiple dose

PLACEBO COMPARATOR

Placebo Hard gelatin capsules filled with cellulose microcrystalline. Single daily dose during five days

Drug: Placebo

Interventions

MBF-015 4 mg oral capsule DRUG

MBF-015 oral capsules Histone deacetylase inhibitor

MBF-015 4mg oral single dose; MBF-015 8 mg oral multiple dose; MBF-015 8 mg oral single dose

MBF-015 16 mg oral capsule DRUG

MBF-015 oral capsules Histone deacetylase inhibitor

MBF-015 16 mg oral multiple dose; MBF-015 16 mg oral single dose; MBF-015 32 mg oral multiple dose; MBF-015 32 mg oral single dose; MBF-015 64 mg oral multiple dose; MBF-015 64 mg oral single dose

Placebo DRUG

Hard gelatin capsules filled with cellulose microcrystalline

Placebo multiple dose; Placebo single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be included in the single dose study, subjects should meet all the following criteria at the screening visit:
• Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
• Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m)2.
• Normal clinical records and physical examination.
• Laboratory tests (haematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
• Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ Diastolic Blood Pressure (DBP) between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
• Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
• To be able to understand the nature of the study and comply with all their requirements.
• Free acceptance to participate in the study should be stated in an informed consent document signed by the volunteer which must be approved by the Clinical Research Ethic Committee (CREC).
• Healthy male and female subjects, 18-45 years (inclusive) of age at the time of enrolment.
• Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
• Normal clinical records and physical examination at screening and baseline.
• Laboratory tests (haematology, biochemistry and urinalysis) within the range of normal values, according to the laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
• Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
• Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.

You may not qualify if:

• For the single dose study and multiple dose study meeting any of the following criteria at screening visit will be excluded from entry into the study:
• History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol \> 40 gr/day for men.
• Heavy consumer of stimulating beverages (\>5 coffees, teas, chocolate or cola drinks per day) and grape juice.
• Background of idiosyncrasy, food intolerance, hypersensitivity or adverse reactions to any drug or Galenic form.
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
• Positive serology for hepatitis B, C or HIV.
• Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
• History of psychiatric diseases or epileptic seizures.
• lead ECG obtained at screening with PR interval ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (\<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
• Having undergone major surgery during the previous 6 months.
• Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
• Participation in other clinical trials during the previous 90 days (drug to drug period) in which an investigational drug or a commercially available drug was tested.
• Donation of blood during the 4 weeks preceding the drug administration.
• Severe or moderate acute illness 4 weeks before drug administration.

Sponsors & Collaborators

• Medibiofarma S.L.: lead

Study Sites (1)

CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Study Officials

• Martinez

  CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: July 7, 2021
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)