Single Ascending Dose Study of PRX002 in Healthy Subjects
NCT ID: NCT02095171
Last Updated: 2015-02-10
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
40 participants
INTERVENTIONAL
2014-03-31
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
QUADRUPLE
Study Groups
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PRX002
PRX002
Placebo
Placebo
Interventions
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PRX002
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception
Exclusion Criteria
* Past or current history of alcohol abuse
* Positive for hepatitis B, hepatitis C or HIV infection
21 Years
65 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Prothena Biosciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa Neumann, PhD
Role: STUDY_DIRECTOR
Clinical Trials Prothena Biosciences Inc
Locations
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San Antonio, Texas, United States
Countries
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Other Identifiers
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PRX002-CL001
Identifier Type: -
Identifier Source: org_study_id
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