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
1 other identifier
interventional
40
1 country
1
Brief Summary
This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 16, 2016
March 1, 2016
9 months
May 28, 2015
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (8)
Safety and tolerability as determined by number of subjects with adverse events
Up to 3 months
Determination of pharmacokinetics parameters-(Cmax)
maximum concentration (Cmax)
Up to 3 months
Determination of pharmacokinetics parameters-(AUClast)
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Up to 3 months
Determination of pharmacokinetics parameters-(AUCinf)
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Up to 3 months
Determination of pharmacokinetics parameters-elimination rate constant
elimination rate constant
Up to 3 months
Determination of pharmacokinetics parameters-(t½)
terminal elimination half life (t½)
Up to 3 months
Determination of pharmacokinetics parameters-(CL)
clearance (CL)
Up to 3 months
Determination of pharmacokinetics parameters-(Vd)
apparent volume of distribution (Vd)
Up to 3 months
Secondary Outcomes (1)
Immunogenicity as determined by measurement of anti-PRX003 antibodies
Up to 3 months
Study Arms (2)
PRX003
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Positive test for drug of abuse
- Past or current history of alcohol abuse
- Positive for TB, hepatitis B, hepatitis C or HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 1, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 16, 2016
Record last verified: 2016-03