A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080

Study Overview
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Brief Summary
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The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Intravenous Doses of BI 765080 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel-group Design)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 765080
* Drug: Placebo


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 (BP, PR), 12-lead ECG, and clinical laboratory tests Age of 18 to 50 years (inclusive) BMI of 18.5 to 29.9 kg/m2 (inclusive) Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation 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 blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm 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 Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders History of relevant orthostatic hypotension, fainting spells, or blackouts Chronic or relevant acute infections A positive poly chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and clinical symptoms suggestive for this disease on Day -2. Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: BI 765080 treatment group<br>BI 765080 | Drug: BI 765080<br>* BI 765080<br>|
| Placebo Comparator: Placebo group<br>Placebo group | Drug: Placebo<br>* Placebo; 0.9% saline for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with drug-related adverse events |  | Up to 87 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) |  | Up to 84 days | 
| Maximum measured concentration of BI 765080 in serum (Cmax) |  | Up to 84 days |