Single Ascending Dose Study of PRX003 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02458677

Enrollment

Registered

2015-06-01

Start date

2015-05-31

Completion date

2016-02-29

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

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

Interventions

DRUGPRX003

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of pharmacokinetics parameters-(Vd)	Up to 3 months	apparent volume of distribution (Vd)
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)

Secondary

Measure	Time frame
Immunogenicity as determined by measurement of anti-PRX003 antibodies	Up to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026