MedTrace Logo

An Exploratory Phase 1 Microdose Study of PRX-105

NCT01093859 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-09-05

No results posted yet for this study

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

DRUG

PRX-105

Sterile solution for intravenous injection

Sponsors & Collaborators

  • Protalix

    lead INDUSTRY

Principal Investigators

  • Einat Almon, PhD · Protalix Ltd.

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-05-31
Completion
2010-08-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093859 on ClinicalTrials.gov