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 |
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.
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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