An Exploratory Phase 1 Microdose Study of PRX-105

Protalix BioTherapeutics

Status and phase: Completed; Early Phase 1

Conditions: Organophosphate Exposure

Treatments: Drug: PRX-105

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093859

PB-09-001

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

PRX-105 Infusion

Experimental group

Treatment:

Drug: PRX-105