Single Ascending Dose Study of PRX002 in Healthy Subjects

February 9, 2015 updated by: Prothena Biosciences Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Experimental: PRX002
Drug: PRX002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability as determined by number of subjects with adverse events
Time Frame: up to 3 months
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- maximum concentration (Cmax)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- time of the maximum measured concentration (Tmax)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- elimination rate constant
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- terminal elimination half life (t½)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- clearance (CL)
up to 3 months
Determination of pharmacokinetics parameters
Time Frame: up to 3 months
- apparent volume of distribution (Vd)
up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prothena Biosciences Limited

Collaborators

Hoffmann-La Roche

Investigators

  • Study Director: Theresa Neumann, PhD, Clinical Trials Prothena Biosciences Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX002-CL001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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