Single Ascending Dose Study of PRX003 in Healthy Subjects

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: PRX003; Other: Placebo

• Registration Number: NCT02458677
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRX003	PRX003	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as determined by number of subjects with adverse events	Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)	Up to 3 months	maximum concentration (Cmax)
Determination of pharmacokinetics parameters-(AUClast)	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)	Up to 3 months	area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters-elimination rate constant	Up to 3 months	elimination rate constant
Determination of pharmacokinetics parameters-(t½)	Up to 3 months	terminal elimination half life (t½)
Determination of pharmacokinetics parameters-(CL)	Up to 3 months	clearance (CL)
Determination of pharmacokinetics parameters-(Vd)	Up to 3 months	apparent volume of distribution (Vd)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity as determined by measurement of anti-PRX003 antibodies	Up to 3 months

Trial Locations

Locations (1)

Worldwide Clinical Trials Early Phase Services; 🇺🇸 San Antonio, Texas, United States