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Single Ascending Dose Study of PRX002 in Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
ClinicalTrials.gov Identifier:
NCT02095171
First received: March 14, 2014
Last updated: April 11, 2014
Last verified: April 2014
  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 Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc:

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
Estimated Primary Completion Date: November 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

Contacts
Contact: Theresa Neumann, PhD (650) 615-2128 theresa.neumann@prothena.com

Locations
United States, Texas
Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
Hoffmann-La Roche
Investigators
Study Director: Theresa Neumann, PhD Clinical Trials Neotope Biosciences Limited
  More Information

No publications provided

Responsible Party: Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
ClinicalTrials.gov Identifier: NCT02095171     History of Changes
Other Study ID Numbers: PRX002-CL001
Study First Received: March 14, 2014
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 27, 2014