An Exploratory Phase 1 Microdose Study of PRX-105

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093859
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : September 5, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Organophosphate Exposure Drug: PRX-105 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: PRX-105 Infusion Drug: PRX-105
Sterile solution for intravenous injection

Primary Outcome Measures :
  1. PRX-105 plasma concentration [ Time Frame: 0 to 48 hours after injection ]
    Assessment of pharmacokinetics

Secondary Outcome Measures :
  1. Cardiovascular monitoring [ Time Frame: 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.

  2. Neurological examination [ Time Frame: 0 to 48 hours ]
    Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking

  3. Ophthalmic evaluation [ Time Frame: 0 to 8 hours ]
    pupillar light reaction, accommodation, visual acuity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01093859

Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Study Director: Einat Almon, PhD Protalix Ltd

Responsible Party: Protalix Identifier: NCT01093859     History of Changes
Other Study ID Numbers: PB-09-001
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Protalix: