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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT07526194

Run by

Boehringer Ingelheim

People needed

72

Starts

2026-04-22

Expected to finish

2026-10-02

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CRS Clinical Research Services Berlin GmbH — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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