A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

Study Overview
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Brief Summary
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The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

Official Title
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Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 3802876
* Drug: Placebo matching BI 3802876


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests Age of ≥18 to ≤55 years at screening Body mass index (BMI) of ≥ 19.0 to ≤ 32.0 kg/m2 at screening. A minimum body weight of 65 kg at screening Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation Exclusion Criteria: Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator Three repeated measurements of systolic BP outside the range of 90 to 140 mm Hg, diastolic BP outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse outside the range of 50 to 90 beats per minute. In case of documented white coat hypertension, the decision for eligibility is left to the investigator. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: BI 3802876 dose group 1<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Experimental: Part A: BI 3802876 dose group 2<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Experimental: Part A: BI 3802876 dose group 3<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Experimental: Part A: BI 3802876 dose group 4<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Experimental: Part A: BI 3802876 dose group 5<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Experimental: Part A: BI 3802876 dose group 6<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Placebo Comparator: Part A: Placebo<br> | Drug: Placebo matching BI 3802876<br>* Placebo matching BI 3802876<br>|
| Experimental: Part B: BI 3802876<br> | Drug: BI 3802876<br>* BI 3802876<br>|
| Placebo Comparator: Part B: Placebo<br> | Drug: Placebo matching BI 3802876<br>* Placebo matching BI 3802876<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP) |  | up to Day 35 for Part A and up to Day 106 for Part B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Day 35 | 
| Part A: Maximum measured concentration of the analyte in serum (Cmax) |  | up to Day 35 | 
| Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state, if steady state can be reasonably assumed (AUCτ,ss) |  | up to Day 106 | 
| Part B: Maximum measured concentration of the analyte in serum at steady state, if steady state can be reasonably assumed (Cmax,ss) |  | up to Day 106 |