Organophosphate ExposureEarly Phase 1NCT01093859
An Exploratory Phase 1 Microdose Study of PRX-105
A Early Phase 1 study testing PRX-105 in people with Organophosphate Exposure, run by Protalix at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Organophosphate Exposure
- What is being tested?
- PRX-105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Aug 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PRX-105
- Keywords
- acetylcholinesterase
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-105Drug
Sterile solution for intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| PRX-105 Infusion | Experimental | Not described Receives: Drug: PRX-105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRX-105 plasma concentration
Assessment of pharmacokinetics
Measured: 0 to 48 hours after injection
Secondary outcomes (3)
Cardiovascular monitoring
Cardiac safety assessment will include ECG for cardiac rhythm and anomalies, and 24 hrs Holter for QT interval evaluation.
Measured: 0 to 48 hours after injection
Neurological examination
Oculomotor and ophthalmic nerves (eye movements and pupil reaction to light), muscle strength, tonus and walking
Measured: 0 to 48 hours
Ophthalmic evaluation
pupillar light reaction, accommodation, visual acuity
Measured: 0 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphate ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protalix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Einat Almon, PhD, Study director, Protalix Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093859
- Sponsor's protocol ID
- PB-09-001
- Status last verified
- Sep 2012
- First submitted
- 24 Mar 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01093859
- Acronym / sponsor ID
- PB-09-001
- Conditions
- Organophosphate Exposure
- Keywords
- acetylcholinesterase
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ProtalixIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRX-105 Infusion | Experimental | Drug: PRX-105 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-105Sterile solution for intravenous injection | Drug | PRX-105 Infusion |
Primary outcome
PRX-105 plasma concentration
Time frame: 0 to 48 hours after injection
Assessment of pharmacokinetics
3 secondary outcomes
Cardiovascular monitoring
Time frame: 0 to 48 hours after injection
Neurological examination
Time frame: 0 to 48 hours
Ophthalmic evaluation
Time frame: 0 to 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einat Almon, PhD study director
Protalix Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRX-105 in people with Organophosphate Exposure, run by Protalix at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRX-105 plasma concentration (time frame: 0 to 48 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.