A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Launched by BOEHRINGER INGELHEIM · Dec 19, 2024
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new medication called BI 3776528 in healthy men to see how well different doses are tolerated and how the body processes it. The study is currently looking for participants who are healthy, between the ages of 18 and 50, and have a body mass index (BMI) within a specific range. To participate, individuals will need to sign a consent form agreeing to take part in the study after understanding its purpose and procedures.
Participants can expect to undergo a thorough medical examination to ensure they meet the health requirements for the trial. This includes checking their blood pressure, heart rate, and other lab tests to confirm they are in good health. Throughout the study, participants will receive either single or multiple doses of the medication and will be closely monitored for any side effects or reactions. It's important to note that those with certain health issues or abnormal test results will not be eligible to join the trial. Overall, the goal of this research is to gather important safety information about BI 3776528, which could be valuable for future treatments.
Gender
MALE
Eligibility criteria
- Inclusion criteria:
- • 1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
- • 2. Age of 18 to 50 years (inclusive)
- • 3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
- • 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Exclusion criteria:
- • 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- • 2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- • 3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
- • 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported