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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

Tracking Information
First Submitted Date  ICMJE March 14, 2014
First Posted Date  ICMJE March 24, 2014
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
  • Safety and tolerability as determined by number of subjects with adverse events [ Time Frame: up to 3 months ]
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - maximum concentration (Cmax)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - time of the maximum measured concentration (Tmax)
  • 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)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - elimination rate constant
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - terminal elimination half life (t½)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - clearance (CL)
  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ]
    - apparent volume of distribution (Vd)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)		 Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Ascending Dose Study of PRX002 in Healthy Subjects
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
Brief Summary This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: PRX002
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: PRX002
    Intervention: Drug: PRX002
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 20, 2014)		 40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02095171
Other Study ID Numbers  ICMJE PRX002-CL001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prothena Biosciences Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prothena Biosciences Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Director: Theresa Neumann, PhD Clinical Trials Prothena Biosciences Inc
PRS Account Prothena Biosciences Limited
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP