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Single Ascending Dose Study of PRX002 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02095171
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : February 10, 2015
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Prothena Biosciences Limited

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: PRX002 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
Study Start Date : March 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRX002 Drug: PRX002
Placebo Comparator: Placebo Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability as determined by number of subjects with adverse events [ Time Frame: up to 3 months ]
  2. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - maximum concentration (Cmax)

  3. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - time of the maximum measured concentration (Tmax)

  4. 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)

  5. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  6. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - elimination rate constant

  7. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - terminal elimination half life (t½)

  8. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - clearance (CL)

  9. Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - apparent volume of distribution (Vd)


Secondary Outcome Measures :
  1. Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095171


Locations
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United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Prothena Biosciences Limited
Hoffmann-La Roche
Investigators
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Study Director: Theresa Neumann, PhD Clinical Trials Prothena Biosciences Inc
More Information
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Responsible Party: Prothena Biosciences Limited
ClinicalTrials.gov Identifier: NCT02095171    
Other Study ID Numbers: PRX002-CL001
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases