Back to resultsSingle Ascending Dose Study of PRX002 in Healthy Subjects
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRX002
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRX002
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability as determined by number of subjects with adverse events
Determination of pharmacokinetics parameters
- maximum concentration (Cmax)
Determination of pharmacokinetics parameters
- time of the maximum measured concentration (Tmax)
Determination of pharmacokinetics parameters
- area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters
- area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters
- elimination rate constant
Determination of pharmacokinetics parameters
- terminal elimination half life (t½)
Determination of pharmacokinetics parameters
- clearance (CL)
Determination of pharmacokinetics parameters
- apparent volume of distribution (Vd)
Secondary Outcome Measures
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Full Information
NCT ID
NCT02095171
First Posted
March 14, 2014
Last Updated
February 9, 2015
Sponsor
Prothena Biosciences Limited
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT02095171
Brief Title
Single Ascending Dose Study of PRX002 in Healthy Subjects
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prothena Biosciences Limited
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRX002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRX002
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as determined by number of subjects with adverse events
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- maximum concentration (Cmax)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- time of the maximum measured concentration (Tmax)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- elimination rate constant
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- terminal elimination half life (t½)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- clearance (CL)
Time Frame
up to 3 months
Title
Determination of pharmacokinetics parameters
Description
- apparent volume of distribution (Vd)
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Immunogenicity as determined by measurement of anti-PRX002 antibodies
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Neumann, PhD
Organizational Affiliation
Clinical Trials Prothena Biosciences Inc
Official's Role
Study Director
Facility Information:
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Ascending Dose Study of PRX002 in Healthy Subjects
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