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A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT07486115•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age of 18 to 65 years (inclusive) at the time of screening
•2. Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
•3. 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
•4. 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.
•5. Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.

Exclusion Criteria

•1. 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
•2. 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)
•3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Locations (1)

SGS Life Science Services - Clinical Research

Edegem, Belgium

Key Dates

Start Date

April 7, 2026

Primary Completion Date

February 15, 2027

Completion Date

February 15, 2027

Last Updated

March 20, 2026

Enrollment

136

ESTIMATED participants

Conditions

Healthy

Interventions

BI 3814916

BIOLOGICAL

Placebo matching BI 3814916

DRUG

Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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