Healthy Adult VolunteersPhase 1NCT02182609
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
A Phase 1 study testing Kit for the Preparation of 99mTc-rhAnnexin V-128 in people with Healthy Adult Volunteers, run by Advanced Accelerator Applications at 1 site in Canada.
Trial summary
The objectives of this study are: To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds. To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Kit for the Preparation of 99mTc-rhAnnexin V-128
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Aug 2015
- Phase
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- No significant medical history
- Normal physical examination
- No clinically significant abnormalities in baseline laboratory values
- No clinically significant abnormalities on 12 lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
- Written informed consent signed
Who cannot join
- Pregnancy or lactation
- Know hypersensitivity to the investigational drug or any of its components
- Current enrolment in another investigational study
- Unwillingness to provide or continue informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of Ottawa Heart Institute
Ottawa, Ontario, ON K1Y 4W7
About this study
Official title: A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers
The objectives of this study are:
- To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
- To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Kit for the Preparation of 99mTc-rhAnnexin V-128
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kit for the Preparation of 99mTc-rhAnnexin V-128Drug
Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-rhAnnexin V-128 | Experimental | Not described Receives: Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Type and incidence of AEs, as well as severity and relatedness to the study medication will be tabulated. Special attention will be given to those subjects who prematurely discontinue the study or the study medication due to an AE, or who experience a severe AE or an SAE.
Measured: Whole study period
Laboratory assessments
Laboratory data (Hematology, coagulation, biochemistry, and urinalysis) will be analysed with respect to the normal ranges of values provided by the local laboratory and with respect to pre-defined levels of change in these values.
Abnormal laboratory test results will be tabulated.
Measured: baseline and 24 hrs, 72 hrs and 30 days after injection
Electrocardiography
ECG parameters will include heart rate (HR), RR interval, PR interval, QRS width and QT interval.
ECG results will be evaluated by means of descriptive statistics and frequency tabulations.
Measured: screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection
Vital signs
Descriptive statistics of the vital signs (pulse rate and blood pressure) observed values as well as for the changes from baseline value will be created. Frequency tabulations with values within, below or above the normal ranges will be made.
Measured: At each study visit
Secondary outcomes (6)
rhAnnexin V-128 serum concentration
In addition to dosimetry, pharmacokinetic will be assessed based on rhAnnexin V-128 serum concentration
Measured: 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection
Whole-body SPECT imaging
The quantitative in vivo biodistribution (whole body dosimetry) of the 99mTc-rhAnnexin V-128 will be determined through whole-body SPECT imaging.
Measured: 30min, 90min, 3hrs, 6hrs and 24 hours post-injection
Blood sample counting
Radioactivity of the whole blood and serum samples will be counted in a gamma counter to assess blood dosimetry and pharmacokinetic.
Measured: baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection
Amount of 99mTc excreted in urine
Measured: One sample at baseline and urine collection within 24 hours post-injection
Amount of 99mTc excreted in faeces
Measured: Baseline and within 24h post injection
Anti-rhAnnexin V-128 IgG and IgM antibodies
Measured: Baseline and 14 and 30 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atreus Pharmaceuticals Corporation
- Responsible party
- Sponsor
- Investigators
- Terrence D. Rudy, MD, FRCPC, Principal investigator, The University of Ottawa Heart Institute, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182609
- Sponsor's protocol ID
- 1001
- Other IDs
- CAAA113A12101
- Status last verified
- Nov 2019
- First submitted
- 1 Jul 2014
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02182609
- Acronym / sponsor ID
- 1001
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Collaborators
- Atreus Pharmaceuticals Corporation
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Jul 2014 (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.
The objectives of this study are:
- To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
- To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-rhAnnexin V-128 | Experimental | Drug: Kit for the Preparation of 99mTc-rhAnnexin V-128 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 65 years
- No significant medical history
- Normal physical examination
- No clinically significant abnormalities in baseline laboratory values
- No clinically significant abnormalities on 12 lead electrocardiogram
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Know hypersensitivity to the investigational drug or any of its components
- Current enrolment in another investigational study
- Unwillingness to provide or continue informed consent
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 |
|---|---|---|
| Kit for the Preparation of 99mTc-rhAnnexin V-128Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection | Drug | 99mTc-rhAnnexin V-128 |
Primary outcome
Adverse events
Time frame: Whole study period
Type and incidence of AEs, as well as severity and relatedness to the study medication will be tabulated. Special attention will be given to those subjects who prematurely discontinue the study or the study medication due to an AE, or who experience a severe AE or an SAE.
Laboratory assessments
Time frame: baseline and 24 hrs, 72 hrs and 30 days after injection
Laboratory data (Hematology, coagulation, biochemistry, and urinalysis) will be analysed with respect to the normal ranges of values provided by the local laboratory and with respect to pre-defined levels of change in these values. Abnormal laboratory test results will be tabulated.
Electrocardiography
Time frame: screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection
ECG parameters will include heart rate (HR), RR interval, PR interval, QRS width and QT interval. ECG results will be evaluated by means of descriptive statistics and frequency tabulations.
Vital signs
Time frame: At each study visit
Descriptive statistics of the vital signs (pulse rate and blood pressure) observed values as well as for the changes from baseline value will be created. Frequency tabulations with values within, below or above the normal ranges will be made.
6 secondary outcomes
rhAnnexin V-128 serum concentration
Time frame: 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection
Whole-body SPECT imaging
Time frame: 30min, 90min, 3hrs, 6hrs and 24 hours post-injection
Blood sample counting
Time frame: baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection
Amount of 99mTc excreted in urine
Time frame: One sample at baseline and urine collection within 24 hours post-injection
Amount of 99mTc excreted in faeces
Time frame: Baseline and within 24h post injection
Anti-rhAnnexin V-128 IgG and IgM antibodies
Time frame: Baseline and 14 and 30 days post-injection
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 21 Nov 2019.
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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.
Terrence D. Rudy, MD, FRCPC principal investigator
The University of Ottawa Heart Institute, The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kit for the Preparation of 99mTc-rhAnnexin V-128 in people with Healthy Adult Volunteers, run by Advanced Accelerator Applications at 1 site in Canada.
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 7 inclusion and 4 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 21 Nov 2019. 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 Canada. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events (time frame: Whole study period). The study lists 4 primary outcomes in all. 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 21 Nov 2019.