Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee (NCT04119687)
An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee
🩺 Plain-English Summary (8th-Grade Level)
This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.
Who can join: Review the eligibility criteria below.
Location: Arizona Research Center — Phoenix, Arizona
Age range: 30 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Arizona Research Center — Phoenix, Arizona
- Gulfcoast Research Institute, LLC — Sarasota, Florida
- Center for Pharmaceutical Research — Kansas City, Missouri
- University Orthopedics Center — Altoona, Pennsylvania
- Altoona Center for Clinical Research — Duncansville, Pennsylvania
- Metroplex Clinical Research Center — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Osteoarthritis, Knee clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.