Organophosphate Exposure
Conditions
Keywords
acetylcholinesterase
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.
Interventions
DRUGPRX-105
Sterile solution for intravenous injection
Sponsors
Protalix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRX-105 plasma concentration | 0 to 48 hours after injection | Assessment of pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Outcome results
None listed