Single Ascending Dose Study of PRX002 in Healthy Subjects

Parkinson's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095171
• Other study ID #: PRX002-CL001
• Status: Completed
• Phase: Phase 1
• First received: March 14, 2014
• Last updated: February 9, 2015
• Start date: March 2014

Study information

• Verified date: February 2015
• Source: Prothena Biosciences Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Positive test for drug of abuse

• Past or current history of alcohol abuse

• Positive for hepatitis B, hepatitis C or HIV infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• PRX002

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Prothena Biosciences Limited	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as determined by number of subjects with adverse events		up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- maximum concentration (Cmax)	up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- time of the maximum measured concentration (Tmax)	up to 3 months	Yes
Primary	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	Yes
Primary	Determination of pharmacokinetics parameters	- area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)	up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- elimination rate constant	up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- terminal elimination half life (t½)	up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- clearance (CL)	up to 3 months	Yes
Primary	Determination of pharmacokinetics parameters	- apparent volume of distribution (Vd)	up to 3 months	Yes
Secondary	Immunogenicity as determined by measurement of anti-PRX002 antibodies		up to 3 months	Yes