An Exploratory Phase 1 Microdose Study of PRX-105
Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Exploratory Phase 1 Study to Assess the Safety and Pharmacokinetics of PRX-105, Administered as a Single, Microdose, Intravenous Slow Bolus Injection to Healthy Volunteers|
- PRX-105 plasma concentration [ Time Frame: 0 to 48 hours after injection ] [ Designated as safety issue: No ]Assessment of pharmacokinetics
- Cardiovascular monitoring [ Time Frame: 0 to 48 hours after injection ] [ Designated as safety issue: Yes ]Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation.
- Neurological examination [ Time Frame: 0 to 48 hours ] [ Designated as safety issue: Yes ]Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking
- Ophthalmic evaluation [ Time Frame: 0 to 8 hours ] [ Designated as safety issue: Yes ]pupillar light reaction, accommodation, visual acuity
|Study Start Date:||March 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
|Experimental: PRX-105 Infusion||
Sterile solution for intravenous injection