NCT01093859

An Exploratory Phase 1 Microdose Study of PRX-105

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Protalix · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Organophosphate Exposure

Interventions

Type	Name	Description
DRUG	PRX-105	Sterile solution for intravenous injection

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2010-03-26
• Last updated: 2012-09-05

Locations

1 site across 1 country: Israel