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Single Ascending Dose Study of PRX002 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Single Ascending Dose Study of PRX002 in Healthy Subjects

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

NCT02095171•Prothena Biosciences Limited

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

San Antonio, Texas, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

December 1, 2014

Last Updated

February 10, 2015

Enrollment

ESTIMATED participants

Conditions

Parkinson's Disease

Interventions

PRX002

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Ascending Dose Study of PRX002 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations