NASHPhase 1NCT06705998
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects
A Phase 1 study testing BAR502 single dose and BAR502 multiple doses in people with NASH, run by BAR Pharmaceuticals s.r.l. at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH
- What is being tested?
- BAR502 single dose and BAR502 multiple doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2024to 3 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 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
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- 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:
- 12 months of spontaneous amenorrhea or
- 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.
- 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
Who cannot join
- 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
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- 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
- Pregnancy (women only): positive or missing pregnancy test at screening or Day -1; child-bearing potential, pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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 to evaluate the safety and tolerability of BAR502 and matching placebo across 4 single ascending doses administered to 4 cohorts of 8 healthy subjects each.
Part B: open label, multiple ascending dose study to evaluate the safety and tolerability of two ascending doses of BAR502, considered as safe in study Part A, when administered as multiple doses to 2 cohorts of 10 healthy subjects each.
- Conditions
- NASH
- Being tested
- BAR502 single dose, Placebo single dose, BAR502 multiple doses
- Keywords
- Non-alcoholic Fatty Liver DIsease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAR502 single doseDrug
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 doseDrug
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 dosesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BAR502 single dose | Experimental | Each subject will receive an oral single-dose of BAR 502 [Study Part A] Receives: Drug: BAR502 single dose |
| Placebo single dose | Placebo comparator | Each subject will receive an oral single-dose of placebo [Study Part A] Receives: 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] Receives: Drug: BAR502 multiple doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Safety will be evaluated through the assessment of adverse events
Measured: 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
Measured: 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
Measured: PART A: Day-1 to Day4; Day 8; - PART B: Day-15/-2 to Day15; Day18
Secondary outcomes (58)
Plasma BAR502 - Study Part A
Plasma BAR502 concentration-time profile after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR502 - Study Part A
Urine BAR502 concentration-time profile after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR505 - Study Part A
Plasma BAR505 concentration-time profiles after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR505 - Study Part A
Urine BAR505 concentration-time profiles after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR502 PK: Cmax - Study Part A
Plasma BAR502 Cmax value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3, Day4
Plasma BAR502 PK: t_max - Study Part A
Plasma BAR502 t_max value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3, Day4
Plasma BAR502 PK: AUC0-t - Study Part A
Plasma BAR502 AUC0-t value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR502 PK: Ae0-t - Study Part A
Urine BAR502 Ae0-t value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Fe0-t - Study Part A
Urine BAR502 Fe0-t value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Rmax - Study Part A
Urine BAR502 Rmax value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: AUR_Clast - Study Part A
Urine BAR502 AUR_Clast value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: REC% - Study Part A
Urine BAR502 REC% value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: tu_max - Study Part A
Urine BAR502 tu_max value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Cl_r r - Study Part A
Urine BAR502 Cl_r r value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker FGF19 - Study Part A
Serum FGF19 baseline-corrected concentration-time profile after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker C4 - Study Part A
Serum C4 baseline-corrected concentration-time profile and PD parameters after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker GLP-1 - Study Part A
Serum GLP-1 baseline-corrected concentration-time profile after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: Cb_max - Study Part A
Serum Cb_max value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: Cb_min - Study Part A
Serum Cb_min value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: tb_max - Study Part A
Serum PD tb_max value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: tb_min - Study Part A
Serum tb_min value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: AUbC_0-24 - Study Part A
Serum AUbC_0-24 value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum PD: partial AUbC - Study Part A
Serum partial AUbC value after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Serum total bile acids - Study Part A
Serum total bile acids baseline-corrected concentration-time profiles after IMP single dose administration
Measured: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR502 concentration - Study Part B
Plasma BAR502 concentration-time profile after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR505 concentration - Study Part B
Plasma BAR505 concentration-time profile after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: Cmax - Study Part B
Plasma BAR502 Cmax value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: t_max - Study Part B
Plasma BAR502 t_max value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: AUC_0-24 - Study Part B
Plasma BAR502 AUC_0-24 value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: AUC_0-t - Study Part B
Plasma BAR502 AUC_0-t value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Serum biomarker GLP-1 - Study Part B
Serum GLP-1 baseline-corrected concentration-time profile after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum biomarker C4 - Study Part B
Serum C4 baseline-corrected concentration-time profile after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum biomarker FGF19 - Study Part B
Serum FGF19 baseline-corrected concentration-time profile after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: Cb_max - Study Part B
Serum Cb_max value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: Cb_min - Study Part B
Serum Cb_min value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: tb_max - Study Part B
Serum tb_max value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: tb_min - Study Part B
Serum tb_min after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: AUbC_0-24 - Study Part B
Serum AUbC_0-24 value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: partial AUbC - Study Part B
Serum partial AUbC value after IMP multiple dose
Measured: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum total bile acids - Study Part B
Serum total bile acids baseline-corrected concentration-time profiles after after IMP multiple dose
Measured: Daily from Day1 to Day17
Change in body weight
Change in body weight from baseline after single and multiple IMP dose
Measured: PART A: Day1; Day 8 - PART B: Day1; Day18; Day30
Check for Physical abnormalities
Change in Physical examination from baseline after single and multiple IMP dose
Measured: PART A: Day1; Day 8 - PART B: Day1; Day18; Day30
hepatic parameters: AST
Change from baseline in AST value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: ALT
Change from baseline in ALT value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: Total bilirubin
Change from baseline in Total bilirubin value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: Direct bilirubin
Change from baseline in Direct bilirubin value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: Indirect bilirubin
Change from baseline in Indirect bilirubin value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: Total cholesterol
Change from baseline in Total cholesterol value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: HDL cholesterol
Change from baseline in HDL cholesterol value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
hepatic parameters: LDL cholesterol
Change from baseline in LDL cholesterol value after single and multiple IMP dose
Measured: PART A: Day2; Day3; Day 8; - PART B: daily from Day2 to Day13; Day15; Day18
Change in Gallbladder contraction - Study Part B
Change from baseline in Gallbladder contraction after IMP multiple dose
Measured: daily from Day2 to Day13; Day15
Change in Gallbladder volume - Study Part B
Change from baseline in Gallbladder volume after IMP multiple dose
Measured: daily from Day2 to Day13; Day15
Change in ECG trace: PR
Change from baseline in ECG trace PR interval value after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Change in ECG trace: QRS
Change from baseline in ECG trace QRS interval value after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Change in ECG trace: QT
Change from baseline in ECG trace QT interval value after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Change in ECG trace: QTcB
Change from baseline in ECG trace QT interval corrected with Bazett's formula after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Change in ECG trace: QTcF
Change from baseline in ECG trace QT interval corrected with Fridericia's formula after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Change in ECG: Heart rate
Change from baseline in ECG Heart rate after single and multiple IMP dose
Measured: PART A: daily from Day1 to Day 4 - PART B: daily from Day to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start4 Dec 2024
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A of the study follows a randomised, double-blind, placebo-controlled, parallel group design. Participants are enrolled in 4 consecutive cohorts of 8 healthy subjects each. In each cohort, the first 2 groups include 2 subjects eahc, while the 3rd group includes 4 subjects. Each group is exposed to IMP only if the Investigator's evaluation of the previous group's safety data is satisfactory and if the competent Ethics Committee gives written authorisation to continue. 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: One ascending doses of IMP 20mg is administered daily for 2 consecutive weeks (14 days) in one cohort of up to 12 healthy subjects by groups of 4 participants each; in case of safety issues the dose is down escalated to 10mg and administered to have at least 10 subjects treated.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- BAR Pharmaceuticals s.r.l.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, CROSS Research S.A., Phase I Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705998
- Sponsor's protocol ID
- BAR-502-001
- Status last verified
- Sep 2026
- First submitted
- 23 Aug 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06705998
- Acronym / sponsor ID
- BAR-502-001
- Conditions
- NASH
- Keywords
- Non-alcoholic Fatty Liver DIsease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BAR Pharmaceuticals s.r.l.Research network
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 to evaluate the safety and tolerability of BAR502 and matching placebo across 4 single ascending doses administered to 4 cohorts of 8 healthy subjects each.
Part B: open label, multiple ascending dose study to evaluate the safety and tolerability of two ascending doses of BAR502, considered as safe in study Part A, when administered as multiple doses to 2 cohorts of 10 healthy subjects each.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part A of the study follows a randomised, double-blind, placebo-controlled, parallel group design. Participants are enrolled in 4 consecutive cohorts of 8 healthy subjects each. In each cohort, the first 2 groups include 2 subjects eahc, while the 3rd group includes 4 subjects. Each group is exposed to IMP only if the Investigator's evaluation of the previous group's safety data is satisfactory and if the competent Ethics Committee gives written authorisation to continue. 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: One ascending doses of IMP 20mg is administered daily for 2 consecutive weeks (14 days) in one cohort of up to 12 healthy subjects by groups of 4 participants each; in case of safety issues the dose is down escalated to 10mg and administered to have at least 10 subjects treated.
| Arm | Type | Receives |
|---|---|---|
| BAR502 single dose | Experimental | Drug: BAR502 single doseEach subject will receive an oral single-dose of BAR 502 [Study Part A] |
| Placebo single dose | Placebo comparator | Drug: Placebo single doseEach subject will receive an oral single-dose of placebo [Study Part A] |
| BAR502 multiple doses | Experimental | Drug: BAR502 multiple dosesEach subject will receive a dose of BAR502 once a day for 14 days [Study Part B] |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAR502 single doseSingle 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). | Drug | BAR502 single dose |
| Placebo single doseMatching 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 | Drug | Placebo single dose |
| BAR502 multiple dosesThe 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. | Drug | BAR502 multiple doses |
Primary outcome
Treatment-emergent adverse events
Time frame: PART A: Day-15/-2; Day-1 to Day4; Day 8; Day15 - PART B: Day-15/-2 to Day18; Day30
Safety will be evaluated through the assessment of adverse events
Change in vital sign - BP
Time frame: PART A: Day-1 to Day4; Day 8; - PART B: Day-15/-2 to Day15; Day18
Tolerability will be evaluated throught the change in Blood preassure from baseline
Change in vital sign - HR
Time frame: PART A: Day-1 to Day4; Day 8; - PART B: Day-15/-2 to Day15; Day18
Tolerability will be evaluated throught the change in Heart rate from baseline
58 secondary outcomes
Plasma BAR502 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR502 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR505 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR505 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR502 PK: Cmax - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3, Day4
Plasma BAR502 PK: t_max - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3, Day4
Plasma BAR502 PK: AUC0-t - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3, Day4
Urine BAR502 PK: Ae0-t - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Fe0-t - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Rmax - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: AUR_Clast - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: REC% - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: tu_max - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Urine BAR502 PK: Cl_r r - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker FGF19 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker C4 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum biomarker GLP-1 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: Cb_max - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: Cb_min - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: tb_max - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: tb_min - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: AUbC_0-24 - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum PD: partial AUbC - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Serum total bile acids - Study Part A
Time frame: Day1 (pre- and post- dose), Day2, Day3
Plasma BAR502 concentration - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR505 concentration - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: Cmax - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: t_max - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: AUC_0-24 - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Plasma BAR502 PK: AUC_0-t - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day18
Serum biomarker GLP-1 - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum biomarker C4 - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum biomarker FGF19 - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: Cb_max - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: Cb_min - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: tb_max - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: tb_min - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: AUbC_0-24 - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum PD: partial AUbC - Study Part B
Time frame: daily from Day1 to Day14 (pre- and post- dose); Day15 to Day17
Serum total bile acids - Study Part B
Time frame: Daily from Day1 to Day17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milko Radicioni, MD principal investigator
CROSS Research S.A., Phase I Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAR502 single dose and BAR502 multiple doses in people with NASH, run by BAR Pharmaceuticals s.r.l. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: PART A: Day-15/-2; Day-1 to Day4; Day 8; Day15 - PART B: Day-15/-2 to Day18; Day30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.