Actively Recruiting
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects
Led by BAR Pharmaceuticals s.r.l. · Updated on 2025-09-22
52
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before joining the study
- Men and women aged 18 to 55 years inclusive
- Body Mass Index between 18.5 and 30 kg/m2 inclusive
- Blood pressure with systolic 100-139 mmHg and diastolic 50-89 mmHg after 5 minutes rest sitting
- Heart rate between 50 and 99 beats per minute
- Ability to understand and cooperate with the study requirements
- Estimated glomerular filtration rate (kidney function) of at least 90 mL/min at screening
- Non-smokers and non-users of nicotine or vaping products for at least 3 months before screening
- Women must be of non-childbearing potential or post-menopausal for at least 1 year, with negative pregnancy tests at screening and Day -1
- Men must be sterile or agree to use approved contraception methods from first dose until 90 days after last dose
You will not qualify if you...
- Abnormal ECG with QTcF > 450 ms
- Significant abnormal physical findings that may affect the study
- Clinically significant abnormal lab values or acute illness at screening
- History of significant kidney, liver, gastrointestinal, heart, lung, skin, blood, hormone, or neurological diseases
- History of gallbladder removal, gallstones, or significant gallbladder issues
- Known allergies or hypersensitivity to study drug or its ingredients
- Use of any medications, supplements, or herbal remedies within 3 weeks before the study
- Participation in investigational drug studies within 3 months before this study
- Blood donation within 3 months before this study
- History of drug, alcohol, or caffeine abuse
- Positive COVID-19 test at Day -1
- Positive cotinine, drug, or alcohol tests at screening or Day -1
- Abnormal diets or substantial recent changes in eating habits; vegetarians and vegans
- Pregnant, lactating, or women with childbearing potential without contraception or negative pregnancy tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CROSS Research S.A. Phase I Unit
Arzo, Switzerland, CH-6864
Actively Recruiting
Research Team
S
Stefano Fiorucci, MD
CONTACT
F
Fania Ferrari, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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