Investigating the safety and effects of BAR502 in healthy individuals

A Phase I, Two Parts Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of BAR502 in Healthy Subjects

This study is testing a new drug called BAR502 in healthy people to see how safe it is and how it works in the body at different doses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: BAR Pharmaceuticals s.r.l. (Research network)
• Locations: 1 site (Arzo)
• Trial ID: NCT06705998 on ClinicalTrials.gov

What this trial studies

This is a first-in-human Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAR502 in healthy subjects. The study consists of two parts: Part A is a randomized, double-blind, placebo-controlled single ascending dose study involving four cohorts of eight participants each, while Part B is an open-label, multiple ascending dose study with two cohorts of ten participants each. The aim is to assess how BAR502 behaves in the body and its safety profile at different doses.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 18-55 with a BMI between 18.5 and 30.

Not a fit: Patients with existing liver disease or those who do not meet the health criteria outlined in the study will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with Non-alcoholic Steatohepatitis (NASH).

How similar studies have performed: Other studies have shown success with similar pharmacokinetic and pharmacodynamic assessments in early-phase trials, but this specific approach with BAR502 is novel.

Eligibility criteria

Inclusion Criteria:

1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and Age: men/women, 18-55 years old inclusive
3. Body Mass Index: 18.5-30 kg/m2 inclusive
4. 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
5. 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
6. 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
7. 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
8. 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:

   1. 12 months of spontaneous amenorrhea or
   2. 6 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.
9. 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:

   1. A male condom with spermicide
   2. A sterile sexual partner or a partner in post-menopausal status for at least 1 year
   3. 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

Exclusion Criteria:

1. ECG 12-leads (supine position): clinically significant abnormalities, in particular QTcF \> 450 ms
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. 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
4. 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
5. Gallbladder: history of cholecystectomy, presence of gallstones or clinically significant gallbladder abnormalities that may interfere with the aim of the study
6. 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
7. Medications: medications, including over the counter medications, homeopathic preparations, vitamins, food supplements and herbal remedies for 3 weeks before the start of the study
8. 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
9. Blood donation: blood donations for 3 months before this study
10. 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
11. SARS-CoV-2 test: positive Covid-19 rapid test at Day -1
12. Cotinine: positive cotinine test at screening
13. Drug test: positive result at the urine drug screening test at screening or Day -1
14. Alcohol test: positive alcohol saliva test at screening or Day -1
15. Diet: abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans
16. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1; child-bearing potential, pregnant or lactating women.

Where this trial is running

Arzo

• CROSS Research S.A. Phase I Unit — Arzo, Switzerland (Recruiting)

Study contacts

• Principal investigator: Milko Radicioni, MD — CROSS Research S.A., Phase I Unit
• Study coordinator: Stefano Fiorucci, MD

Conditions NASH; Non-alcoholic Fatty Liver DIsease