NCT05203367

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

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BAR Pharmaceuticals s.r.l. · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	BAR502	Single oral doses of BAR 502/placebo will be administered as film-coated tablets, in the morning of Day 1, with 240 mL of water, after an overnight fasting of at least 8 hours. BAR 502 film-coated tablets are available at dose strengths of 10, 50 and 150 mg. A maximum of 4 dose levels are pre-planned (10 mg, 50 mg, 150 mg, 300 mg).
DRUG	Placebo	Matching BAR 502 placebo film-coated tablets will be given to 2 out of 8 subjects in each cohort using the same regimen as outlined for the active study treatment

Timeline

• Start date: 2022-11-25
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2022-01-24
• Last updated: 2024-06-20

Locations

1 site across 1 country: Portugal