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NCT Number: NCT01093859

An Exploratory Phase 1 Microdose Study of PRX-105

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.

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Key information

Conditions

Organophosphate Exposure Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRX-105

Drug

Sterile solution for intravenous injection

Primary outcomes

  1. PRX-105 plasma concentration

    Time frame: 0 to 48 hours after injection

    Assessment of pharmacokinetics

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Protalix

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2010
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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