Actively Recruiting

Phase 1
Age: 18Years - 50Years
MALE
Healthy Volunteers
NCT06916702

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

Led by Boehringer Ingelheim · Updated on 2026-02-17

60

Participants Needed

1

Research Sites

82 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 (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.

CONDITIONS

Official Title

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

Who Can Participate

Age: 18Years - 50Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male subjects as confirmed by medical history, physical exam, vital signs, ECG, and lab tests
  • Age 18 to 50 years (inclusive)
  • Body Mass Index (BMI) from 20.0 to 29.9 kg/m2 and body weight at least 60 kg
  • Signed informed consent according to ICH-GCP and local laws before joining the trial
Not Eligible

You will not qualify if you...

  • Any abnormal medical exam findings considered clinically relevant by the investigator
  • Systolic blood pressure outside 90 to 139 mmHg, diastolic blood pressure outside 50 to 89 mmHg, or pulse rate outside 50 to 90 bpm at screening
  • Laboratory values outside reference ranges deemed clinically relevant by the investigator
  • Evidence of any clinically relevant concomitant disease
  • Additional exclusion criteria as applicable

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

Charité Research Organisation GmbH

Berlin, Germany, 10117

Actively Recruiting

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Research Team

B

Boehringer Ingelheim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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