A Study of Single Dose RO6811135 in Healthy Volunteers
- Registration Number
- NCT01676584
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers. Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135 or placebo subcutaneously.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Healthy male and female volunteers, 18 to 45 years of age inclusive
- Body mass index (BMI) 22-32 kg/m2 inclusive
- Females of child-bearing potential and males with female partners of child-bearing potential must agree to use adequate contraception as defined by protocol
Exclusion Criteria
- History or presence of any clinically relevant disease or disorder
- History of drug hypersensitivity or food allergies
- Significant infection or known inflammatory process at screening or Day -1
- Any history of alcohol and/or drug of abuse addiction
- Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week
- Smoking more than 5 cigarettes a day or equivalent amount of tobacco
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug or device study within 3 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - RO6811135 RO6811135 -
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 3 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Area under the concentration-time curve Pre-dose and up to 96 hours post-dose Pharmacodynamics (blood analysis) of RO6811135 96 hours