To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects

PHASE1RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

December 4, 2024

Primary Completion Date

May 15, 2026

Study Completion Date

July 30, 2026

Conditions
NASH
Interventions
DRUG

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)."

DRUG

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

DRUG

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.

Trial Locations (1)

CH-6864

RECRUITING

CROSS Research S.A. Phase I Unit, Arzo

Sponsors
All Listed Sponsors
lead

BAR Pharmaceuticals s.r.l.

NETWORK