RecruitingPhase 1NCT07486115

A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People

A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BI 3814916 in Healthy Male and Female Subjects

Sponsor

Boehringer Ingelheim

Enrollment

136 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

Age of 18 to 65 years (inclusive) at the time of screening
Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Agree to refrain from strenuous or unusual exercise/activity (for example heavy lifting, weight training, intense aerobics classes, etc.) for at least 72 hours prior to study visits.
Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.

Exclusion Criteria3

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Interested in this trial?

Get notified about updates and connect with the research team.