A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
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This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.
Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male healthy volunteers, 18-45 years of age inclusive
Healthy as determined by screening assessments
Body mass index (BMI) between 18-30 kg/m2
Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
Any history of alcohol and/or drug of abuse addiction during the past 5 years
Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
Any clinically relevant abnormal test results prior to first dosing
Positive for hepatitis B, hepatitis C or HIV infection
Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1