[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers

Summary

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.

Timeline

Start

2018-08-16

Primary completion

2019-05-31

Completion

2019-06-30

Drugs

Indications