Single Ascending Dose Study of PRX003 in Healthy Subjects
NCT ID: NCT02458677
Last Updated: 2016-03-16
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
2015-05-31
2016-02-29
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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PRX003
PRX003
Placebo
Placebo
Interventions
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PRX003
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 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 TB, hepatitis B, hepatitis C or HIV infection
21 Years
50 Years
ALL
Yes
Sponsors
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Prothena Biosciences Limited
INDUSTRY
Responsible Party
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Locations
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Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, United States
Countries
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Other Identifiers
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PRX003-CL001
Identifier Type: -
Identifier Source: org_study_id
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