A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults

Launched by BOEHRINGER INGELHEIM · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how safe and tolerable a new medication called BI 3810477 is when given in multiple doses to healthy adults. The researchers want to see how the drug behaves in the body and if it causes any side effects. The study is not yet recruiting participants, but it will involve both men and women aged 18 to 60 who meet specific health criteria.

To join the trial, participants must be healthy, meaning they pass a thorough medical check-up, including a physical exam and lab tests. They should have a body mass index (BMI) between 18.5 and 29.9, which is a measure of body weight relative to height. If selected, participants can expect to take the medication over a set period and will be closely monitored for their health and any reactions to the drug. It’s important to note that individuals with certain medical conditions or abnormal test results will not be eligible for this study to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
• • Age of 18 to 60 years (inclusive, to be checked at time of signing informed consent).
• • BMI of 18.5 to 29.9 kg/m2 (inclusive).
• • Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
• • Further inclusion criteria apply.
• Exclusion Criteria:
• • Any finding in the medical examination (including BP, PR, RR, temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator.
• • Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm).
• • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
• • Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
• • Further exclusion criteria apply.