Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers
Condition: Healthy
Intervention: BI 655064; Placebo
Intervention description: subcutaneous injection; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the safety and tolerability of multiple
      doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese
      male volunteers.

      The secondary objective is the exploratory evaluation of the pharmacokinetics and
      pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4
      weeks in healthy Chinese male volunteers.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males according to the investigator's assessment, as based on the following
             criteria: a complete medical history including a physical examination, vital signs
             (Blood pressure, Pulse rate), 12-lead Echocardiogram, and clinical laboratory tests

          2. Chinese ethnicity according to the following criteria:

             Ethnic Chinese, born in China or ethnic Chinese born outside of China, and a
             descendent of 4 ethnic Chinese grandparents who were all born in China

          3. Age within the range of 20 to 45 years inclusive

          4. Body Mass Index within the range of 18.5 and 25 kg/m2 inclusive

          5. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and the local legislation

          6. Male subjects who

               -  are documented to be sterile or consistently and correctly use a condom while
                  their female partners (if of childbearing potential) agree to use any of the
                  following adequate contraception methods: implants, injectables, combined oral
                  contraceptives, intrauterine device (IUD) from the date of screening until at
                  least 6 months after the last dose of BI 655064 taken in the current trial.

               -  do not donate any sperm sample for procreation purposes, from the date of
                  screening until at least 6 months after last dose of BI 655064 taken in the
                  current trial.

        It is the responsibility of the male subject to ensure that his partner does not become
        pregnant during all the study duration.

        Exclusion criteria:

          1. Any finding in the medical examination (including Blood pressure, Pulse rate or
             Echocardiogram) deviating from normal and judged clinically relevant by the
             investigator

          2. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          3. Any evidence of a concomitant disease judged clinically relevant by the investigator

          4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          5. Diseases of the central nervous system (such as epilepsy), other neurological
             disorders or psychiatric disorders

          6. History of relevant orthostatic hypotension, fainting spells, or blackouts

          7. History of relevant allergy/hypersensitivity (including allergy to the trial
             medication or its excipients)

          8. Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10
             half-lives of the respective drug prior to administration of trial medication

          9. Within 10 days prior to administration of trial medication, use of drugs that might
             reasonably influence the results of the trial

         10. Participation in another trial with investigational drug administration within 60 days
             prior to administration of trial medication

         11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)

         12. Inability to refrain from smoking on trial days

         13. Alcohol abuse (consumption of more than 20 g/day)

         14. Drug abuse or positive drug screen

         15. Blood donation (more than 100 mL within 30 days prior to administration of trial
             medication or intended during the trial)

         16. Intention to commence new exercise regimen or excessive physical activities within one
             week prior to administration of trial medication or during the trial

         17. Inability to comply with protocol requirements (including dietary regimen of trial
             site) as assessed by the investigator

         18. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc
             interval > 450 ms) at screening examination

         19. Positive results of infectious serology (Hepatitis B Surface Antigen, Hepatitis B Core
             Antibody, Hepatitis C Antibody or Human Immunodeficiency Virus) at screening
             examination

         20. History of tuberculosis infection and/or positive Quantiferon Tuberculosis-Gold test
             at screening examination

         21. Abnormal results of coagulation values indicating an increased risk for bleeding or
             thromboembolism or complicating the safety evaluation during the study as determined
             by the investigator at screening examination

         22. Subjects who in the investigator's judgement are perceived as having an excessive risk
             of thromboembolism for example because of a personal history and/or a first degree
             relative with a personal history with onset under the age of 55 of significant
             thromboembolism, including but not limited to deep vein thrombosis, pulmonary
             embolism, cortical sinus thrombosis, coronary and cerebrovascular events, and
             peripheral arterial insufficiency.

         23. Deficiency of antithrombin III or protein S or protein C at screening examination

         24. Prolongation of bleeding time out of reference range at screening examination

         25. Subject is assessed by the investigator as unsuitable for inclusion e.g. considered
             not able to understand and comply with study requirements or has a condition that
             would not allow safe participation in the study