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Single Ascending Dose Study of PRX003 in Healthy Subjects

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRX003
Placebo
Sponsored by
Prothena Biosciences Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects
  • Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 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 TB, hepatitis B, hepatitis C or HIV infection

Sites / Locations

  • Worldwide Clinical Trials Early Phase Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX003

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability as determined by number of subjects with adverse events
Determination of pharmacokinetics parameters-(Cmax)
maximum concentration (Cmax)
Determination of pharmacokinetics parameters-(AUClast)
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters-(AUCinf)
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters-elimination rate constant
elimination rate constant
Determination of pharmacokinetics parameters-(t½)
terminal elimination half life (t½)
Determination of pharmacokinetics parameters-(CL)
clearance (CL)
Determination of pharmacokinetics parameters-(Vd)
apparent volume of distribution (Vd)

Secondary Outcome Measures

Immunogenicity as determined by measurement of anti-PRX003 antibodies

Full Information

First Posted
May 28, 2015
Last Updated
March 14, 2016
Sponsor
Prothena Biosciences Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02458677
Brief Title
Single Ascending Dose Study of PRX003 in Healthy Subjects
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prothena Biosciences Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRX003
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRX003
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as determined by number of subjects with adverse events
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(Cmax)
Description
maximum concentration (Cmax)
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(AUClast)
Description
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(AUCinf)
Description
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-elimination rate constant
Description
elimination rate constant
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(t½)
Description
terminal elimination half life (t½)
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(CL)
Description
clearance (CL)
Time Frame
Up to 3 months
Title
Determination of pharmacokinetics parameters-(Vd)
Description
apparent volume of distribution (Vd)
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Immunogenicity as determined by measurement of anti-PRX003 antibodies
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 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 TB, hepatitis B, hepatitis C or HIV infection
Facility Information:
Facility Name
Worldwide Clinical Trials Early Phase Services
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Single Ascending Dose Study of PRX003 in Healthy Subjects

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