Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Single Ascending Dose Study of PRX002 in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Prothena Biosciences Limited
ClinicalTrials.gov Identifier:
NCT02095171
First received: March 14, 2014
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Drug: PRX002
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Prothena Biosciences Limited:

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

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - time of the maximum measured concentration (Tmax)

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - 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 ] [ Designated as safety issue: Yes ]
    - area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - elimination rate constant

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - terminal elimination half life (t½)

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - clearance (CL)

  • Determination of pharmacokinetics parameters [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    - apparent volume of distribution (Vd)


Secondary Outcome Measures:
  • Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRX002 Drug: PRX002
Placebo Comparator: Placebo Other: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02095171

Locations
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Prothena Biosciences Limited
Hoffmann-La Roche
Investigators
Study Director: Theresa Neumann, PhD Clinical Trials Prothena Biosciences Inc
  More Information

No publications provided

Responsible Party: Prothena Biosciences Limited
ClinicalTrials.gov Identifier: NCT02095171     History of Changes
Other Study ID Numbers: PRX002-CL001
Study First Received: March 14, 2014
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015