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

March 14, 2014
April 11, 2014
March 2014
November 2014   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT02095171 on ClinicalTrials.gov Archive Site
Immunogenicity as determined by measurement of anti-PRX002 antibodies [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single Ascending Dose Study of PRX002 in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: PRX002
  • Other: Placebo
  • Experimental: PRX002
    Intervention: Drug: PRX002
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact: Theresa Neumann, PhD (650) 615-2128 theresa.neumann@prothena.com
United States
 
NCT02095171
PRX002-CL001
Not Provided
Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
Hoffmann-La Roche
Study Director: Theresa Neumann, PhD Clinical Trials Neotope Biosciences Limited
Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
April 2014

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