Single Ascending Dose Study of PRX002 in Healthy Subjects
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 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 PRX002 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
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFebruary 10, 2015
February 1, 2015
9 months
March 14, 2014
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (9)
Safety and tolerability as determined by number of subjects with adverse events
up to 3 months
Determination of pharmacokinetics parameters
\- maximum concentration (Cmax)
up to 3 months
Determination of pharmacokinetics parameters
\- time of the maximum measured concentration (Tmax)
up to 3 months
Determination of pharmacokinetics parameters
\- 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
\- area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
up to 3 months
Determination of pharmacokinetics parameters
\- elimination rate constant
up to 3 months
Determination of pharmacokinetics parameters
\- terminal elimination half life (t½)
up to 3 months
Determination of pharmacokinetics parameters
\- clearance (CL)
up to 3 months
Determination of pharmacokinetics parameters
\- apparent volume of distribution (Vd)
up to 3 months
Secondary Outcomes (1)
Immunogenicity as determined by measurement of anti-PRX002 antibodies
up to 3 months
Study Arms (2)
PRX002
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 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
You may not qualify if:
- Positive test for drug of abuse
- Past or current history of alcohol abuse
- Positive for hepatitis B, hepatitis C or HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prothena Biosciences Limitedlead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Theresa Neumann, PhD
Clinical Trials Prothena Biosciences Inc
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
March 14, 2014
First Posted
March 24, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2014
Last Updated
February 10, 2015
Record last verified: 2015-02