phase II: suspected coronary artery disease MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Code: SYN2
Pharmaceutical Form: Solution for injection
Product Code: SYN2
Pharmaceutical Form: Solution for injection
Sponsors
Synektik Spólka Akcyjna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I Inclusion Criteria 1. Must be willing and able to provide signed written informed consent prior to any study related procedures; 2. Male or Female, over 18 years of age; 3. Body mass index =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Phase I: Exclusion Criteria: 1. Any clinically significant acute or chronic unstable physical or psychological disease based on medical history or screening physical examination; 2. Any clinically significant abnormality in the screening laboratory tests or ECG; 3. Any exposure to any investigational drugs within four (4) weeks prior to Visit 1; 4. Any exposure to investigational radiopharmaceuticals within 12 months prior to the date of Visit 1; 5. Any new prescription medications within four (4) weeks of Visit 1; 6. Subject has a positive (+)pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding. 7. Subject has experienced any allergic reaction to similar compounds or agents. 8. Subject has a positive SARS-CoV-2 test result on screening. Phase II: Exclusion Criteria: 1. Patients who are unable to undergo all the imaging procedures based on the investigators opinion. Reasons may be any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination. 2. Patients who have an established diagnosis of CAD as confirmed by any of the following: 1. Previous myocardial infarction (MI); 2. Previous cardiac catheter angiography showing =50% stenosis; 3. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement. 3. Patients incapable of undergoing pharmacological cardiac stress testing. 4. Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing. 5. Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%). 6. Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA (e.g. balloon angioplasty or bypass syrgery). 7. Patients without abnormalities in the SPECT MPI performed at screening visit (V0). 8. Patients undergoing evaluation for heart transplantation or with history of heart transplantation. 9. Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study 10. Female subject has a positive (+) pregnancy test, the possibility of pregnancy cannot be ruled out prior to dosing, or the subject is breast-feeding. 11. Subject has a positive SARS-CoV-2 test result on screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To assess safety and tolerability of a single dose of SYN2 in healthy volunteers Phase II: To assess safety and tolerability of SYN2 in patients with suspected CAD and referral to ICA. ;Secondary Objective: Phase I: To determine distribution of 18F after i.v. administration of SYN2 to calculate internal radiation dosimetry and the effective dose in healthy subjects. To assess pharmacokinetics of SYN2 to determine a mathematical model for a software used for quantitation of myocardial perfusion. Phase II: To assess diagnostic ability of Myocardial Perfusion Imaging with SYN2 in patients with suspected CAD and referral to ICA. ;Primary end point(s): Phase I: Adverse events and reportable serious adverse as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0 including but not limited to changes in laboratory parameters, ECG parameters, physical examination, vital signs, volunteer reported events. P hase II: Adverse events and reportable serious adverse as defined by the NCI Common Toxicity Criteria for Adverse Events; CTCAE v.5.0 including but not limited to changes in laboratory parameters, ECG parameters, physical examination, vital signs. ;Timepoint(s) of evaluation of this end point: Phase I: screening, day-1, Days 1 to 3, 48 h (±8 h) post dose; 5 days (±2 days) post-dose 14 days (±2 days) post-dose Phase II:V0, V1, V2,V3,V4 V0-Screening, V1, V2, V3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: Internal radiation dose and the effective dose as well as biodistribution of the SYN2 in healthy subjects. Data on kinetic behaviour of SYN2 in heart and circulation as well as on SYN2 metabolites. Phase II: Diagnostic ability of SYN2 in the detection of CAD using ICA with FFR as the reference standard. ;Timepoint(s) of evaluation of this end point: Phase I: Day 1 Phase II: V1, V2 | — |
Countries
Poland
Contacts
Public ContactCRO company
Clinscience Sp. z o.o.
Outcome results
None listed