RecruitingPhase 1NCT06575400

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

A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Subcutaneous Doses of BI 3804379 in Healthy Male and Female Subjects

Sponsor

Boehringer Ingelheim

Enrollment

106 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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)

Exclusion Criteria4

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.

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