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

NCT06705998 | Recruiting Phase 1 DMC

• 1 other identifier: BAR-502-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NASH

Keywords

Non-alcoholic Fatty Liver DIsease

Outcome Measures

Primary Outcomes (3)

• Treatment-emergent adverse events

  Safety will be evaluated through the assessment of adverse events

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

• Change in vital sign - BP

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

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

• Change in vital sign - HR

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

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

Secondary Outcomes (58)

• Plasma BAR502 - Study Part A

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

• Urine BAR502 - Study Part A

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

• Plasma BAR505 - Study Part A

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

• Urine BAR505 - Study Part A

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

• Plasma BAR502 PK: Cmax - Study Part A

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

Study Arms (3)

BAR502 single dose

EXPERIMENTAL

Each subject will receive an oral single-dose of BAR 502 \[Study Part A\]

Drug: BAR502 single dose

Placebo single dose

PLACEBO COMPARATOR

Each subject will receive an oral single-dose of placebo \[Study Part A\]

Drug: Placebo single dose

BAR502 multiple doses

EXPERIMENTAL

Each subject will receive a dose of BAR502 once a day for 14 days \[Study Part B\]

Drug: BAR502 multiple doses

Interventions

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).

BAR502 single dose

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

Placebo single dose

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.

BAR502 multiple doses

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
• Renal functionality: estimated glomerular filtration rate calculated using the Cockcroft-Gault equation and normalized to an average surface area of 1.73 m2 ≥ 90 mL/min at screening
• Tobacco: non-smokers, non-users of nicotine containing products and non-users of Vapo e-cigarettes for at least 3 months prior to study screening
• Contraception and fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year, defined as such when there is either:
• months of spontaneous amenorrhea or
• weeks documented postsurgical bilateral oophorectomy with or without hysterectomy will be admitted. For all women, pregnancy test result must be negative at screening and on Day -1 of each study part.
• Contraception (men only): men will either be sterile or agree to use one of the following approved methods of contraception from the first investigational medicinal product administration until at least 90 days after the last administration, also in case their partner is currently pregnant:
• A male condom with spermicide
• A sterile sexual partner or a partner in post-menopausal status for at least 1 year
• Use by the female sexual partner of an IUD, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit or: True abstinence

You may not qualify if:

• 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
• Gallbladder: history of cholecystectomy, presence of gallstones or clinically significant gallbladder abnormalities that may interfere with the aim of the study
• Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
• Medications: medications, including over the counter medications, homeopathic preparations, vitamins, food supplements and herbal remedies for 3 weeks before the start of the study
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
• Blood donation: blood donations for 3 months before this study
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>1 drink/day for females and \>2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025\] or caffeine (\>5 cups coffee/tea/day) abuse
• SARS-CoV-2 test: positive Covid-19 rapid test at Day -1
• Cotinine: positive cotinine test at screening
• Drug test: positive result at the urine drug screening test at screening or Day -1
• Alcohol test: positive alcohol saliva test at screening or Day -1
• Diet: abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans

Sponsors & Collaborators

• BAR Pharmaceuticals s.r.l.: lead

Study Sites (1)

CROSS Research S.A. Phase I Unit

Arzo, CH-6864, Switzerland

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

BAR502

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Milko Radicioni, MD

  CROSS Research S.A., Phase I Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Fiorucci, MD

CONTACT

+3905221403366; stefano.fiorucci@unipg.it

Fania Ferrari, BSc

CONTACT

f.ferrari@barpharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind: Active or placebo
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The Part A of the study follows a randomised, double-blind, placebo-controlled, parallel group design. The participants are enrolled in 4 consecutive cohorts of 8 healthy subjects each. In each cohort, the first 2 groups include 2 subjects each, while the 3rd group in each cohort includes 4 subjects. Each group of subjects is exposed to the treatment under investigation only if the Investigator's evaluation of the previous group's safety data up to 72 h post-dose is satisfactory and if the competent Ethics Committee gives written authorisation to continue with the next group. At the end of each cohort, before proceeding to the next dose level, safety and tolerability results up to 168 h post-dose (Day 8) are evaluated by a Data Safety Monitoring Board. Part B of the study: Two ascending doses of IMP identified in study Part A, are subsequentially administered as daily multiple doses for 2 consecutive weeks (14 days) in two cohorts of 10 healthy subjects each.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: November 26, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)