A Study of Single Dose RO6811135 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01676584

Run by

Hoffmann-La Roche

People needed

56

Starts

2012-09-01

Expected to finish

2012-12-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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