An Exploratory Phase 1 Microdose Study of PRX-105
This study has been completed.
Sponsor:
Protalix
Information provided by (Responsible Party):
Protalix
ClinicalTrials.gov Identifier:
NCT01093859
First received: March 24, 2010
Last updated: September 4, 2012
Last verified: September 2012
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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 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 May 16, 2013