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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
intravenous infusion of escalating doses
subcutaneous injection of escalating doses
intravenous infusion of escalating doses
1293.1.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Changes in vital signs (blood pressure [BP], pulse rate [PR])
Time frame: up to 70 days post treatment
Changes in 12-lead ECG (electrocardiogram)
Time frame: up to 70 days post treatment
Incidence of adverse events
Time frame: up to 70 days post treatment
Assessment of global tolerability by investigator
Time frame: up to 70 days post treatment
Assessment of local tolerability by investigator
Time frame: up to 70 days post treatment
Maximum measured concentration of the analyte in plasma
Time frame: 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
Time frame: 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
Time frame: up to 1656 hours post treatment
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subcutaneous injection of escalating doses