Single Ascending Dose Study of PRX002 in Healthy Subjects

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: PRX002; Other: Placebo

• Registration Number: NCT02095171
• Lead Sponsor: Prothena Biosciences Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRX002	PRX002	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Determination of pharmacokinetics parameters	up to 3 months	- apparent volume of distribution (Vd)
Safety and tolerability as determined by number of subjects with adverse events	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Immunogenicity as determined by measurement of anti-PRX002 antibodies	up to 3 months