A Study of Single Dose RO6811135 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: placebo; Drug: RO6811135

• 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

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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