A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.

Hoffmann-La Roche0 sites56 target enrollmentSeptember 2012

ConditionsHealthy Volunteer

Interventionsplacebo RO6811135

DrugsRO6811135 placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 56
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: placebo

RO6811135

Intervention: RO6811135

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: approximately 3 months

Secondary Outcomes

Pharmacokinetics: Area under the concentration-time curve(Pre-dose and up to 96 hours post-dose)
Pharmacodynamics (blood analysis) of RO6811135(96 hours)