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

ConditionNASH

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorBAR Pharmaceuticals s.r.l.

About this trial

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.

Eligibility criteria

Qualifiers

Informed consent: signed written informed consent before inclusion in the study

Sex and Age: men/women, 18-55 years old inclusive

Body Mass Index: 18.5-30 kg/m2 inclusive

Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position

Disqualifiers

ECG 12-leads (supine position): clinically significant abnormalities, in particular QTcF > 450 ms

Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study

Laboratory analyses: clinically significant abnormal laboratory values at screening indicative of physical illness or any acute laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude participation in the study of an investigational compound. INR > 1.2

Diseases: significant history of renal, hepatic (in particular, liver or hepatobiliary diseases as indicated by serum alanine aminotransferase, aspartate aminotransferase or total bilirubin levels exceeding the upper limit of normality), gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study

Trial design

Treatments tested in this trial

BAR502 single dose
Placebo single dose
BAR502 multiple doses

Treatment groups

52 Participants

are divided into 3 treatment groups

Sponsors and collaborators

BAR Pharmaceuticals s.r.l.

Lead sponsor

Source ClinicalTrials.gov