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Recruiting Phase 1 NCT06745297

A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

Trial Parameters

Condition Healthy
Sponsor Boehringer Ingelheim
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 142
Sex MALE
Min Age 18 Years
Max Age 50 Years
Start Date 2025-01-23
Completion 2026-08-25
Interventions
BI 3776528Placebo matching BI 3776528short-acting benzodiazepine

Brief Summary

The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.

Eligibility Criteria

Inclusion criteria: 1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory. 2. Age of 18 to 50 years (inclusive) 3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Exclusion criteria: 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement at screening 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 beats per minute (bpm) 3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical releva

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