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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male Japanese subjects following intravenous administration of single rising doses.
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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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
Japanese ethnicity, according to the following criteria, born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
Age of 18 to 45 years (inclusive) at screening visit
BMI of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of infusion of trial medication until 90 days after end of infusion of trial medication:
Exclusion criteria
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Interventional model
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32 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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