Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

Study Overview
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Brief Summary
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To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo to BI 655064
* Drug: Placebo to BI 655064
* Drug: BI 655064
* Drug: BI 655064


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 655064 subcutaneous<br>Escalating single dose as solution for subcutaneous injection | Drug: BI 655064<br>* subcutaneous injection of escalating doses<br>|
| Placebo Comparator: Placebo to BI 655064 subcutaneous<br>Escalation single dose as solution for subcutaneous injection (Placebo) | Drug: Placebo to BI 655064<br>* subcutaneous injection of escalating doses<br>|
| Experimental: BI 655064 intravenous<br>Escalating single dose as solution for intravenous infusion | Drug: BI 655064<br>* intravenous infusion of escalating doses<br>|
| Placebo Comparator: Placebo to BI 655064 intravenous<br>Escalating single dose as solution for intravenous infusion (Placebo) | Drug: Placebo to BI 655064<br>* intravenous infusion of escalating doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vital signs (blood pressure [BP], pulse rate [PR]) |  | up to 70 days post treatment | 
| Changes in 12-lead ECG (electrocardiogram) |  | up to 70 days post treatment | 
| Incidence of adverse events |  | up to 70 days post treatment | 
| Assessment of global tolerability by investigator |  | up to 70 days post treatment | 
| Assessment of local tolerability by investigator |  | up to 70 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured concentration of the analyte in plasma |  | up to 1656 hours post treatment | 
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity |  | up to 1656 hours post treatment | 
| Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose |  | up to 1656 hours post treatment |