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

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 Overview

• Status: Completed
• Conditions: Organophosphate Exposure
• Intervention / Treatment: Drug: PRX-105

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteers aged 18-45 (inclusive) years.
• Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.
• Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
• Blood pressure and heart rate within normal limits.
• Electrocardiogram (ECG) with no clinically significant abnormalities.

Exclusion Criteria:

• History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
• Current / previous occupational exposure to organophosphates or pesticides.
• Previous receipt of any investigational butyrylcholinesterase product.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRX-105 Infusion	Drug: PRX-105; Sterile solution for intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRX-105 plasma concentration	Assessment of pharmacokinetics	0 to 48 hours after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular monitoring	Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation.	0 to 48 hours after injection
Neurological examination	Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking	0 to 48 hours
Ophthalmic evaluation	pupillar light reaction, accommodation, visual acuity	0 to 8 hours

Collaborators and Investigators

• Sponsor: Protalix
• Investigators: Study Director: Einat Almon, PhD, Protalix Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: acetylcholinesterase
• Other Study ID Numbers: PB-09-001