Trials / Completed
CompletedNCT02865434
Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA
An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Navidea Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.
Detailed description
A Manocept Platform prospective, open-label, multicenter, dose escalation, safety with PK and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging. All subjects will receive IV administration at one of 3 mass doses: 50 µg, 200 µg, or 400 µg. Within each mass dose group, subjects will receive Tc 99m tilmanocept labeled with one of 3 radiolabel doses: 1 mCi, 5 mCi, or 10 mCi. All subjects will have a whole body planar SPECT scan. Subjects enrolled in Groups 1-9 will receive a whole body and planar hands scan followed by SPECT/CT scans on areas of interest post injection at 60 minutes ± 15 minutes and 180 minutes ± 15 minutes. Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed at 4 specified time points post injection: 15 ± 5 minutes, 60 ± 15 minutes, 180 ± 15 minutes and 18-20 hours. Planar hand scans will be collected at 60 ± 15 minutes and 180 ± 15 minutes post-injection. PK blood sampling will be performed before injection (within 15 minutes), immediately following injection (within 5 minutes) and at each scanning timepoint. Dosimetry tests will be performed at each scanning timepoint. PK of urine will be assessed through counts of the bladder wall obtained from cumulative quantitative planar imaging from radiation dosimetry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tc99m-tilmanocept | Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. |
| PROCEDURE | SPECT Imaging (60 Minutes post-injection) | Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection. |
| PROCEDURE | SPECT Imaging (180 Minutes post-injection) | Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection. |
| PROCEDURE | Whole body planar SPECT imaging (15 Minutes post-injection) | Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry. |
| PROCEDURE | Whole body planar SPECT imaging (60 Minutes post-injection) | Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry. |
| PROCEDURE | Whole body planar SPECT imaging (180 Minutes post-injection) | Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry. |
| PROCEDURE | Whole body planar SPECT imaging (18-20 Hours post-injection) | Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry. |
| PROCEDURE | Blood Collection for PK Testing (15 Mins Before Injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept |
| PROCEDURE | Blood Collection for PK Testing (after injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00) |
| PROCEDURE | Blood Collection for PK Testing (15 minutes post injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept |
| PROCEDURE | Blood Collection for PK Testing (60 minutes post injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept |
| PROCEDURE | Blood Collection for PK Testing (180 minutes post injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept |
| PROCEDURE | Blood Collection for PK Testing (18-20 hours post injection) | Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept |
| PROCEDURE | Planar Image with both Hands in Field of View | Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2016-08-12
- Last updated
- 2021-08-12
- Results posted
- 2021-08-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02865434. Inclusion in this directory is not an endorsement.