Status:
ACTIVE_NOT_RECRUITING
A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 3810477 in healthy male and female trial participants when given as multiple rising doses.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2026
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06984926
Start Date
June 6 2025
End Date
March 9 2026
Last Update
December 19 2025
Active Locations (1)
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1
SGS Life Science Services - Clinical Research
Edegem, Belgium, 2650