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

NCT07486115 | Not Yet Recruiting Phase 1

• 3 other identifiers: 1543-00012025-523262-25-001111-1325-7389
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator

  up to 111 days

Secondary Outcomes (4)

• 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

Study Arms (4)

Part A: single rising dose arm

EXPERIMENTAL

Biological: BI 3814916

Part A: placebo arm

PLACEBO COMPARATOR

Drug: Placebo matching BI 3814916

Part B: multiple rising dose arm

EXPERIMENTAL

Biological: BI 3814916

Part B: placebo arm

PLACEBO COMPARATOR

Drug: Placebo matching BI 3814916

Interventions

BI 3814916 BIOLOGICAL

BI 3814916

Part A: single rising dose arm; Part B: multiple rising dose arm

Placebo matching BI 3814916 DRUG

Placebo matching BI 3814916

Part A: placebo arm; Part B: placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Single rising dose (SRD) Part B: Multiple rising dose (MRD)

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 12, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)