A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

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.

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.

Inclusion Criteria:

• Male healthy volunteers, 18-45 years of age inclusive
• Healthy as determined by screening assessments
• Body mass index (BMI) between 18-30 kg/m2

Exclusion Criteria:

• 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