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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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • BAR502 single dose

    Drug

    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

    Drug

    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

    Drug

    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.

Treatment groups

52 Participants
are divided into 3 treatment groups
Group A: BAR502 single doseExperimental treatment 1 intervention
Group B: Placebo single dosePlacebo comparator 1 intervention
Group C: BAR502 multiple dosesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-emergent adverse events

Safety will be evaluated through the assessment of adverse events

Time frame
PART A: Day-15/-2; Day-1 to Day4; Day 8; Day15 - PART B: Day-15/-2 to Day18; Day30
2

Change in vital sign - BP

Tolerability will be evaluated throught the change in Blood preassure from baseline

Time frame
PART A: Day-1 to Day4; Day 8; - PART B: Day-15/-2 to Day15; Day18
3

Change in vital sign - HR

Tolerability will be evaluated throught the change in Heart rate from baseline

Time frame
PART A: Day-1 to Day4; Day 8; - PART B: Day-15/-2 to Day15; Day18

Secondary outcomes

1

Plasma BAR502 - Study Part A

Plasma BAR502 concentration-time profile after IMP single dose administration

Time frame
Day1 (pre- and post- dose), Day2, Day3, Day4
2

Urine BAR502 - Study Part A

Urine BAR502 concentration-time profile after IMP single dose administration

Time frame
Day1 (pre- and post- dose), Day2, Day3
3

Plasma BAR505 - Study Part A

Plasma BAR505 concentration-time profiles after IMP single dose administration

Time frame
Day1 (pre- and post- dose), Day2, Day3, Day4
4

Urine BAR505 - Study Part A

Urine BAR505 concentration-time profiles after IMP single dose administration

Time frame
Day1 (pre- and post- dose), Day2, Day3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BAR Pharmaceuticals s.r.l.

Lead sponsor

Source ClinicalTrials.gov
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