RecruitingPhase 1NCT06745297

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

A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants

Sponsor

Boehringer Ingelheim

Enrollment

172 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

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

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria3

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
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)
Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.

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