An Exploratory Phase 1 Microdose Study of PRX-105

Study Overview
=================
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.

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

Conditions
-----------------
Organophosphate Exposure

Intervention / Treatment
-----------------
* Drug: PRX-105


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX-105 Infusion<br> | Drug: PRX-105<br>* Sterile solution for intravenous injection<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetylcholinesterase