An Exploratory Phase 1 Microdose Study of PRX-105

Early Phase 1

Completed

• Conditions: Organophosphate Exposure
• Interventions: Drug: PRX-105

• Registration Number: NCT01093859
• Lead Sponsor: Protalix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRX-105 Infusion	PRX-105	-

Primary Outcome Measures

Name	Time	Method
PRX-105 plasma concentration	0 to 48 hours after injection	Assessment of pharmacokinetics

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel