This goal of this open label study is to evaluate the safety and tolerability of a single intra-articular administration of ABR1 in adults with knee osteoarthritis with a KL grade from 2 to 4. The primary questions it aims to answer are:
1. Is ABR1 safe to use as an intraarticular injection for participants with knee osteoarthritis? 2. What medical problems do participants have after receiving a single injection of ABR1?
Participants will receive a single injection of ABR1 to the knee with osteoarthritis. Participants will
1. Keep a stable pain treatment regimen 2. Visit the clinic at 1 week, 4 weeks, 8 weeks, and 12 weeks post injection 3. Keep a diary of their symptoms and number of times they use a rescue medication for their knee pain.
Male or female at least 40years of age
Knee OA with Kellgren-Lawrence (KL) Grade 2 to 4 of the target knee on X-ray
Inadequate pain relief with 1st line treatment, consisting of any of the following
conservative non-pharmacological treatment AND/OR
Pregnant or lactating
Other significant knee pathologies of target knee from medical history or radiographic method(s)
Severe malalignment > 10 degree in the target knee (either varus or valgus) measured using standardized knee x-ray at screening or based on previous medical records
Severe inflammatory arthritis or other joint disease with warm, red, and swollen knee in the target knee
Pleryon Therapeutics (Hangzhou) Limited
Lead sponsor