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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-08-25

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo; 0.9% saline for injection

10 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

25 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

50 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

100 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

200 mg BI 765080

BI 765080

Group Type EXPERIMENTAL

BI 765080

Intervention Type DRUG

BI 765080

Interventions

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BI 765080

Intervention Type DRUG

Placebo

Placebo; 0.9% saline for injection

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes