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Study to Assess the Safety and Tolerability of MBF-118 in Healthy Volunteers

NCT05921916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-09-21

No results posted yet for this study

Summary

This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-118 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 cancer.

Conditions

Interventions

DRUG

MBF-118 oral capsules

MBF-118 oral capsules PPAR gamma receptor partial agonist

DRUG

Placebo oral capsule

Placebo oral capsule solid microcrystalline cellulose

Sponsors & Collaborators

  • Medibiofarma S.L.

    lead INDUSTRY

Principal Investigators

  • Joan Martinez, MD · CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2022-09-06
Completion
2022-09-06

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921916 on ClinicalTrials.gov