RecruitingPhase 1

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

Belgium106 participantsStarted 2024-09-12

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Healthy male or female (of non-child-bearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
✓. Age of 18 to 65 years (inclusive)
✓. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
✓. 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 Further inclusion criteria apply

Exclusion criteria

✕. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
✕. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (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.
✕. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

What they're measuring

SRD part and MRD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator

Timeframe: Up to Day 84 for SRD part and up to Day 235 for MRD part.

Trial details

NCT IDNCT06575400

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-02

Contact for this trial

Boehringer Ingelheim

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

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