RecruitingPhase 1NCT07526194

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

A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 3821001 Administered to Healthy Trial Participants

Sponsor

Boehringer Ingelheim

Enrollment

72 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

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

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

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)

Exclusion Criteria3

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

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