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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02095171

Enrollment

Registered

2014-03-24

Start date

2014-03-31

Completion date

Unknown

Last updated

2015-02-10

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

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

21 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability as determined by number of subjects with adverse events	up to 3 months	—
Determination of pharmacokinetics parameters	up to 3 months	\- maximum concentration (Cmax)

Secondary

Measure	Time frame
Immunogenicity as determined by measurement of anti-PRX002 antibodies	up to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026