Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06575400

A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

Led by Boehringer Ingelheim · Updated on 2026-03-31

106

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.

CONDITIONS

Official Title

A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female (of non-child-bearing potential) subjects based on medical history, physical exam, vital signs, ECG, and lab tests
  • Age between 18 and 65 years (inclusive)
  • Body mass index (BMI) between 18.5 and 30.0 kg/m2 (inclusive)
  • Signed and dated informed consent following ICH-GCP and local laws prior to trial admission
Not Eligible

You will not qualify if you...

  • Any clinically relevant abnormal finding in medical exam including blood pressure, pulse rate, or ECG
  • Repeated systolic blood pressure outside 90-140 mmHg, diastolic blood pressure outside 45-90 mmHg, or pulse rate outside 45-100 bpm
  • Any clinically relevant abnormal laboratory value
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders considered clinically relevant by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SGS Life Science Services - Clinical Research

Edegem, Belgium, 2650

Actively Recruiting

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Research Team

B

Boehringer Ingelheim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People | DecenTrialz