52
Participants
Start Date
December 4, 2024
Primary Completion Date
May 15, 2026
Study Completion Date
July 30, 2026
BAR502 single dose
"Single oral doses of BAR 502/placebo will be administered as film-coated tablets, in the morning of Day 1, with 150 mL of water, after an overnight fasting of at least 8 hours.~BAR 502 film-coated tablets are available at dose strengths of 3, 10 and 50mg. A maximum of 4 dose levels are pre-planned (3, 10, 30 and 60mg)."
Placebo single dose
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
BAR502 multiple doses
The 2 multiple ascending doses selected based on results of study part A will be administered to 2 study cohorts of 10 subjects each. The IMP will be orally administered once a day from Day 1 to Day 14, at 8:00±1 h, for a total of 14 doses.
RECRUITING
CROSS Research S.A. Phase I Unit, Arzo
Lead Sponsor
BAR Pharmaceuticals s.r.l.
NETWORK