Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02157714

Enrollment

Registered

2014-06-06

Start date

2014-06-30

Completion date

Unknown

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

Interventions

DRUGPRX002

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Idiopathic Parkinson's disease, Hoehn and Yahr 1-3 * Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs * 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

* Significant cardiac history * Abnormal MRI * Significant laboratory abnormalities

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability as determined by number of subjects with adverse events	up to 6 months	—
Determination of pharmacokinetics parameters	up to 6 months	maximum concentration (Cmax)

Secondary

Measure	Time frame	Description
Immunogenicity as determined by measurement of anti-PRX002 antibodies	up to 3 months	Multiple clinical and exploratory biomarkers will be assessed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026