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A Study of RO6926496 in Healthy Volunteers

NCT ID: NCT02281786

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.

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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Cohort 1

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Cohort 2

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Cohort 3

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Cohort 4

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Cohort 5

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Cohort 6

8 volunteers (6 active, 2 placebo)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo to RO6926496

RO6926496

Intervention Type DRUG

single, ascending dose, intravenous administration

Interventions

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Placebo

Matching placebo to RO6926496

Intervention Type DRUG

RO6926496

single, ascending dose, intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male participants, 18 to 45 years of age; healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history
* A body mass index between 18 and 30 kg/m2
* Male subjects and their partners of childbearing potential must agree to use 2 methods of contraception, one of which must be a barrier method for the duration of the study

Exclusion Criteria

* Positive hepatitis B, hepatitis C, or HIV infection
* History of any clinically significant disease or disorder
* Clinically significant abnormalities in laboratory test results
* Participation in an investigational drug or device study within 90 days prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* History or presence of clinically significant ECG abnormalities
* Smokers who smoke more than 10 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-clinic period
* Any clinically relevant history of hypersensitivity or allergic reactions
* Any familial history of early onset Alzheimer's disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

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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Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-003170-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP29462

Identifier Type: -

Identifier Source: org_study_id