Rion Inc.
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis
Knee Osteoarthritis
PEP/Euflexxa
PEP
PHASE1
Study Plan (with Dose Escalation): Arm 1 and Arm 2 will run in parallel such that initially 3 subjects will be enrolled in Arm 1a (PEP Low Dose) and 3 subjects will be enrolled in Arm 2a (PEP-EUFLEXXA Low Dose). After all 6 subjects complete the 30 day follow up and there was not more than 1 AE grade 3 or higher per Arm, a further 9 subjects will be enrolled in Arm 1b (PEP High Dose) and a further 9 subjects will be enrolled in Arm 2b (PEP-EUFLEXXA High Dose).
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 24 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | Phase 1b Open-Label, Multi-Center, Randomized Trial to Evaluate the Safety of PEP and EUFLEXXA for the Treatment of Subjects With Knee Osteoarthritis (KOA) |
Actual Study Start Date : | 2024-11-01 |
Estimated Primary Completion Date : | 2025-11-01 |
Estimated Study Completion Date : | 2025-11-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 90 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905