RecruitingPhase 1

A Study in Healthy Men to Test How Well Different Doses of BI 3821001 Are Tolerated

Germany72 participantsStarted 2026-04-22

Plain-language summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male trial participant 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
✓. Age of 18 to 55 years (inclusive)
✓. Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
✓. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply

✕. Any finding in the medical examination (including BP, PR 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

Timeframe: Up to 60 days

NCT IDNCT07526194

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-02

Boehringer Ingelheim

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy male trial participant 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
✓. Age of 18 to 55 years (inclusive)
✓. Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
✓. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply

✕. Any finding in the medical examination (including BP, PR 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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