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A Study of Single Dose RO6811135 in Healthy Volunteers

NCT ID: NCT01676584

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single doses sc

RO6811135

Group Type EXPERIMENTAL

RO6811135

Intervention Type DRUG

single ascending doses sc

Interventions

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RO6811135

single ascending doses sc

Intervention Type DRUG

placebo

single doses sc

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BP28410

Identifier Type: -

Identifier Source: org_study_id