An Exploratory Phase 1 Microdose Study of PRX-105

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Protalix
ClinicalTrials.gov Identifier:
NCT01093859
First received: March 24, 2010
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Organophosphate Exposure
Drug: PRX-105
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Protalix:

Primary Outcome Measures:
  • PRX-105 plasma concentration [ Time Frame: 0 to 48 hours after injection ] [ Designated as safety issue: No ]
    Assessment of pharmacokinetics


Secondary Outcome Measures:
  • Cardiovascular monitoring [ Time Frame: 0 to 48 hours after injection ] [ Designated as safety issue: Yes ]
    Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation.

  • Neurological examination [ Time Frame: 0 to 48 hours ] [ Designated as safety issue: Yes ]
    Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking

  • Ophthalmic evaluation [ Time Frame: 0 to 8 hours ] [ Designated as safety issue: Yes ]
    pupillar light reaction, accommodation, visual acuity


Enrollment: 10
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRX-105 Infusion Drug: PRX-105
Sterile solution for intravenous injection

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093859

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

No publications provided

Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT01093859     History of Changes
Other Study ID Numbers: PB-09-001
Study First Received: March 24, 2010
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Protalix:
acetylcholinesterase

ClinicalTrials.gov processed this record on September 30, 2014