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Single Ascending Dose Study of PRX003 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02458677
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Prothena Biosciences Limited

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: PRX003 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: PRX003 Drug: PRX003
Placebo Comparator: Placebo Other: Placebo



Primary Outcome Measures :
  1. Safety and tolerability as determined by number of subjects with adverse events [ Time Frame: Up to 3 months ]
  2. Determination of pharmacokinetics parameters-(Cmax) [ Time Frame: Up to 3 months ]
    maximum concentration (Cmax)

  3. Determination of pharmacokinetics parameters-(AUClast) [ Time Frame: Up to 3 months ]
    area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)

  4. Determination of pharmacokinetics parameters-(AUCinf) [ Time Frame: Up to 3 months ]
    area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  5. Determination of pharmacokinetics parameters-elimination rate constant [ Time Frame: Up to 3 months ]
    elimination rate constant

  6. Determination of pharmacokinetics parameters-(t½) [ Time Frame: Up to 3 months ]
    terminal elimination half life (t½)

  7. Determination of pharmacokinetics parameters-(CL) [ Time Frame: Up to 3 months ]
    clearance (CL)

  8. Determination of pharmacokinetics parameters-(Vd) [ Time Frame: Up to 3 months ]
    apparent volume of distribution (Vd)


Secondary Outcome Measures :
  1. Immunogenicity as determined by measurement of anti-PRX003 antibodies [ Time Frame: Up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458677


Locations
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United States, Texas
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, United States
Sponsors and Collaborators
Prothena Biosciences Limited
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Responsible Party: Prothena Biosciences Limited
ClinicalTrials.gov Identifier: NCT02458677    
Other Study ID Numbers: PRX003-CL001
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases