Actively Recruiting
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Led by Boehringer Ingelheim · Updated on 2025-11-21
142
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
CONDITIONS
Official Title
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male subjects as determined by medical history, physical exam, and lab tests
- Age between 18 and 50 years inclusive
- Body mass index (BMI) between 18.5 and 29.9 kg/m² and body weight above 60 kg
- Signed informed consent according to regulations
You will not qualify if you...
- Any clinically relevant abnormal findings in medical exam, including blood pressure, pulse, or electrocardiogram
- Systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50-90 mmHg on repeated screening
- Pulse rate outside 50-90 beats per minute on repeated screening
- Laboratory values outside normal age-adjusted ranges, especially liver enzymes, bilirubin, creatinine, or abnormal thyroid stimulating hormone on repeated tests
- Any clinically relevant concomitant disease as assessed by the investigator
- Further exclusion criteria not detailed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charité Research Organisation GmbH
Berlin, Germany, 10117
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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