An Exploratory Phase 1 Microdose Study of PRX-105

NCT01093859 | Completed Early Phase 1

• 1 other identifier: PB-09-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Organophosphate Exposure

Keywords

acetylcholinesterase

Outcome Measures

Primary Outcomes (1)

• PRX-105 plasma concentration

  Assessment of pharmacokinetics

  0 to 48 hours after injection

Secondary Outcomes (3)

• Cardiovascular monitoring

  0 to 48 hours after injection

• Neurological examination

  0 to 48 hours

• Ophthalmic evaluation

  0 to 8 hours

Study Arms (1)

PRX-105 Infusion

EXPERIMENTAL

Drug: PRX-105

Interventions

PRX-105 DRUG

Sterile solution for intravenous injection

PRX-105 Infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protalix: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

PRX-105

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Einat Almon, PhD

  Protalix Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

IL (1)