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OpenTrials
Completed

NCT Number: NCT02095171

Single Ascending Dose Study of PRX002 in Healthy Subjects

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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 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

Treatment and study plan

PRX002

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

    Time frame: up to 3 months

    • maximum concentration (Cmax)

  3. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • time of the maximum measured concentration (Tmax)

  4. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)

  5. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  6. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • elimination rate constant

  7. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • terminal elimination half life (t½)

  8. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • clearance (CL)

  9. Determination of pharmacokinetics parameters

    Time frame: up to 3 months

    • apparent volume of distribution (Vd)

Secondary outcomes

  1. Immunogenicity as determined by measurement of anti-PRX002 antibodies

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Prothena Biosciences Limited

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
First posted
Mar 24, 2014
Registry last updated
Feb 10, 2015

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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