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

NCT05203367 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

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

Sponsors & Collaborators

  • BAR Pharmaceuticals s.r.l.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-25
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Portugal

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203367 on ClinicalTrials.gov