Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects

Status Withdrawn

Clinical Trial Summary

This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.

Clinical Trial Description

This clinical trial will be the first-in-Human (FiH) study of BAR 502.

This study is planned to investigate up to 4 dose levels of BAR 502. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male: female) to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo (ratio 3:1, active: placebo).

The study is designed to meet the following objectives:

• Primary:

• To evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.

• Secondary:

• To investigate the pharmacokinetics (PK) of single-ascending doses of BAR 502 in healthy male and female subjects;

• To investigate the pharmacodynamics (PD) of single-ascending doses of BAR 502 in healthy male and female subjects. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

• NCT number: NCT05203367
• Study type: Interventional
• Source: BAR Pharmaceuticals s.r.l.
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 25, 2022
• Completion date: March 30, 2023