A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
NCT ID: NCT02427243
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2015-04-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Crenezumab Formulation 2
A single dose given as two subcutaneous injections on Day 1
Crenezumab
Crenezumab Formulation 3
A single dose given as two subcutaneous injections on Day 1
Crenezumab
Interventions
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Crenezumab
Crenezumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 18.5 to 32 kg/m\^2, inclusive
* Body weight 50 to 100 kg, inclusive
* Females must be of non-childbearing potential
* Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later
Exclusion Criteria
* History of alcoholism or drug addiction within 6 months prior to CRU Check-in
* Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in
18 Years
65 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Evansville, Indiana, United States
Dallas, Texas, United States
Countries
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Other Identifiers
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GP29172
Identifier Type: -
Identifier Source: org_study_id