A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PRX003
- Conditions
- Psoriasis
- Sponsor
- Prothena Biosciences Limited
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and tolerability as determined by number of subjects with adverse events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
Investigators
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
Arms & Interventions
PRX003
Intervention: PRX003
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability as determined by number of subjects with adverse events
Time Frame: Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
Time Frame: Up to 3 months
maximum concentration (Cmax)
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)
Determination of pharmacokinetics parameters-(AUCinf)
Time Frame: Up to 3 months
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters-elimination rate constant
Time Frame: Up to 3 months
elimination rate constant
Determination of pharmacokinetics parameters-(t½)
Time Frame: Up to 3 months
terminal elimination half life (t½)
Determination of pharmacokinetics parameters-(CL)
Time Frame: Up to 3 months
clearance (CL)
Determination of pharmacokinetics parameters-(Vd)
Time Frame: Up to 3 months
apparent volume of distribution (Vd)
Secondary Outcomes
- Immunogenicity as determined by measurement of anti-PRX003 antibodies(Up to 3 months)