Single Ascending Dose Study of PRX002 in Healthy Subjects



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 65
Updated:2/7/2015
Start Date:March 2014
Contact:Theresa Neumann, PhD
Email:theresa.neumann@prothena.com
Phone:(650) 615-2128

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A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and
immunogenicity of PRX002 in approximately 40 healthy subjects.


Inclusion Criteria:

- Healthy subjects

- 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:

- Positive test for drug of abuse

- Past or current history of alcohol abuse

- Positive for hepatitis B, hepatitis C or HIV infection
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