NCT02095171
Completed
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PRX002
- Conditions
- Parkinson's Disease
- Sponsor
- Prothena Biosciences Limited
- Enrollment
- 40
- Primary Endpoint
- Determination of pharmacokinetics parameters
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.
Investigators
Eligibility Criteria
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
Arms & Interventions
PRX002
Intervention: PRX002
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- apparent volume of distribution (Vd)
Safety and tolerability as determined by number of subjects with adverse events
Time Frame: up to 3 months
Secondary Outcomes
- Immunogenicity as determined by measurement of anti-PRX002 antibodies(up to 3 months)
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