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An Exploratory Phase 1 Microdose Study of PRX-105

NCT ID: NCT01093859

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Organophosphate Exposure

Keywords

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acetylcholinesterase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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PRX-105 Infusion

Group Type EXPERIMENTAL

PRX-105

Intervention Type DRUG

Sterile solution for intravenous injection

Interventions

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PRX-105

Sterile solution for intravenous injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Protalix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Einat Almon, PhD

Role: STUDY_DIRECTOR

Protalix Ltd.

Locations

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PB-09-001

Identifier Type: -

Identifier Source: org_study_id