A Study of Single Dose RO6811135 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/3/2016 |
| Start Date: | September 2012 |
| End Date: | December 2012 |
A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.
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.
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.
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
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