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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: BI 3814916; Drug: Placebo matching BI 3814916

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • SGS Life Science Services - Clinical Research
    • Contact: Boehringer Ingelheim; Phone Number: 080049616; Email: belgique@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Further inclusion criteria apply.

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
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: single rising dose arm	Biological: BI 3814916; BI 3814916
Placebo Comparator: Part A: placebo arm	Drug: Placebo matching BI 3814916; Placebo matching BI 3814916
Experimental: Part B: multiple rising dose arm	Biological: BI 3814916; BI 3814916
Placebo Comparator: Part B: placebo arm	Drug: Placebo matching BI 3814916; Placebo matching BI 3814916

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator	up to 111 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 72 days
Part A: Maximum measured concentration of the analyte in serum (Cmax)	up to 72 days
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed	up to 108 days
Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed	up to 108 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 12, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1543-0001; 2025-523262-25-00 (Ctis); 1111-1325-7389 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No