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OpenTrials
Completed

NCT Number: NCT02458677

Single Ascending Dose Study of PRX003 in Healthy Subjects

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials Early Phase Services

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRX003

Drug

Placebo

Other

Primary outcomes

  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 outcomes

  1. Immunogenicity as determined by measurement of anti-PRX003 antibodies

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Prothena Biosciences Limited

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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