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

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 43 participants (planned 52)
    • Study completion date changed from estimate of Jul 30, 2026 to Jun 3, 2026
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 19 of 58 entries
    • Site details revised
  2. Primary completion date: Aug 15, 2025 to May 15, 2026
    • Study completion date: Sep 30, 2025 to Jul 30, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 15, 2024 to Dec 4, 2024
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
First-in-human, single centre, two parts, dose-escalation, parallel-group, safety, tolerability, pharmacokinetic and pharmacodynamic Phase I study. Part A: randomised, double-blind, placebo-controlled, single ascending dose study. Part B: open label, multiple ascending dose study.
Trial Details
NCT Number NCT06705998
Lead Sponsor BAR Pharmaceuticals s.r.l.
Conditions
(from sponsor)		 NASH
Related terms Non-alcoholic Fatty Liver Disease
Enrollment 43 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov