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.
This first-in-human study is a single-site, open-label, single-arm investigation in adults with knee osteoarthritis from KL grade 2 to 4 evaluating safety and tolerability of a single, ultrasound-guided intra-articular injection of ABR1, while also observing any signals of symptom improvement over 24 weeks post-injection. All enrolled participants will receive a single administration of ABR1 intraarticularly in the target knee and will be followed per protocol for safety monitoring and clinical assessments. Participants should continue to take their medications for pre-existing medical conditions as usual during the trial. Participants will be advised that they may use study allowed rescue medication to treat worsening pain. Participants will record any rescue medication use in their Participant Diary. Researchers will assess the incidence of adverse events, its relatedness to the device, and the incidence of any treatment-related serious adverse events through Week 12. Patient reported outcomes related to knee osteoarthritis pain will be observed up to Week 24 post injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Received a single dose of ABR1
Royal North Shore Hospital
Sydney, New South Wales, Australia
Number of adverse events
Incidence of treatment-emergent adverse events (TEAEs) through Week 12
Time frame: from the day receiving study intervention (day 0) to 12 weeks after study intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.