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
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.
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. ;
NCT number | NCT05203367 |
Study type | Interventional |
Source | BAR Pharmaceuticals s.r.l. |
Contact | Marlene Fonseca, MD |
Phone | +351220959020 |
[email protected] | |
Status | Not yet recruiting |
Phase | Phase 1 |
Start date | February 25, 2022 |
Completion date | April 30, 2022 |
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