An Exploratory Phase 1 Microdose Study of PRX-105

Organophosphate Exposure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093859
• Other study ID #: PB-09-001
• Status: Completed
• Phase: Phase 0
• First received: March 24, 2010
• Last updated: September 4, 2012
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: September 2012
• Source: Protalix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Organophosphate Exposure

Intervention

Drug:
• PRX-105
Sterile solution for intravenous injection

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Protalix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRX-105 plasma concentration	Assessment of pharmacokinetics	0 to 48 hours after injection	No
Secondary	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	Yes
Secondary	Neurological examination	Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking	0 to 48 hours	Yes
Secondary	Ophthalmic evaluation	pupillar light reaction, accommodation, visual acuity	0 to 8 hours	Yes