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The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety monitoring. Healthy volunteers will also have their whole body imaged and have extra blood drawn to determine where T-087 goes in the body. These additional procedures will be done on the same day as the ip administration, and repeated the following day. All subjects will have a final follow-up phone call within 2- 3 business days following the ip administration.
This is a Phase 1, non-randomized, open label, single centre clinical trial. 6 healthy volunteers (3 male and 3 female,4 study visits) and 6-18 subjects with Osteoarthritis of the knee (3 study visits) will be enrolled. At visit 2, all subjects will have knee pain assessed, using a visual analogue scale, prior to receiving a single, 555 MBq (15 mCi)+/-10% dose of [Tc-99m)-RPI-T-087 injection. Knees will be imaged with a SPECT/CT camera at specified time-points post injection. Safety monitoring will include vital signs, ECG, clinical laboratory tests (serum biochemistry, haematology, urinalysis) and adverse event monitoring.
Additionally, HVs will have whole body planar imaging and blood sampling conducted at Visit 2 and 3 to evaluate bio-distribution, estimate dosimetry and measure clearance of total activity over time in blood samples. A final follow-up visit will be conducted by phone interview.
Once 6 HVs and 6 KOA participants have completed the study, a blinded assessment of the image data will be conducted to determine whether any more KOA subjects should be imaged.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry. |
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| Osteo Arthritis of the knee | Experimental | Subjects with knee osteoarthritis will be administered [Tc-99m]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [Tc-99m]-RPI-T-087 Injection | Drug | A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | The incidence of adverse events, including injection site reactions, clinically significant changes in clinical laboratory parameters (blood and urine), ECG's and vital signs, will be summarized over time to assess safety and tolerability. | Up to 3 days post investigative product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake over time | Quantitative standard uptake values (SUV) for T-087 will be determined for the knees of subjects with KOA and HVs, and comparing uptake in the target knee of OA subjects with the uptake in the knees of the HVs. | Up to 4.5 hours post administration of the investigational product |
| Image quality |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of [Tc-99m]-RPI-T-087 | Blood sampling (HVs only) will support the exploratory objective of using radioactivity measurements (if measurable) to assess the clearance of [Tc-99m]-RPI-T-087. | Up to 1 day post administration of the investigational product. |
Inclusion Criteria :
Subjects with Knee Osteoarthritis (KOA)
For Healthy Volunteers:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Crouch, BScc, MRT(N) | Contact | (905) 522-1155 | 35019 | jcrouch@stjoes.ca |
| MaryLou Lawlor, RN | Contact | (905) 522-1155 | 33790 | mlawlor@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Karen Gulenchyn, MD | St. Joseph's Hospital Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | Canada |
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This is a Phase 1, non-randomized, open-label, single-centre clinical trial. A total of 12 to 24 subjects will be enrolled:
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A visual assessment using a scoring system will be used to assess the SPECT/CT images quality in subjects with KOA. Image quality scales of 1 to 3, with 1 as unacceptable (non-interpretable quality), 2 as adequate quality for interpretation and 3 as excellent quality (no issues) of the target knee will be descriptively summarized by time point and subject group. |
| Up to 4.5 hours post administration of the investigational product |
| Dosimetry | Whole body planar imaging of healthy volunteers will be used to evaluate the biodistribution of [Tc-99m]-RPI-T-087 Injection to estimate dosimetry. Whole body scintigraphic images will be quantified as to fractional activity (IA) in various visceral organs (e.g., liver, lungs, heart) as well as routes of excretion, total body and knees. The data describing the uptake, retention and clearance in these tissues will characterize the biodistribution and biokinetics of the IP. These data also serve as the foundation for radiation dose estimates for the IP. | Up to 1 day post administration of the investigational product. |