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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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05203367
Study type Interventional
Source BAR Pharmaceuticals s.r.l.
Contact Marlene Fonseca, MD
Phone +351220959020
Status Not yet recruiting
Phase Phase 1
Start date November 25, 2022
Completion date March 30, 2023

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