PCRX-201 (enekinragene inzadenovec)
Safety and Tolerability of PCRX-201 for Patients With Painful Osteoarthritis of the Knee
Summary1
Condition: Knee osteoarthritis
Treatment: PCRX-201
Male & Female
Age Range: 30–80 years
6 Locations
Phase 1
What is this study about?
- This study is exploring the safety and tolerability of PCRX-201, an investigational treatment designed to help relieve pain and inflammation in people with knee osteoarthritis (OA). Knee OA causes joint pain, stiffness, and reduced movement. Researchers aim to learn how well PCRX-201 is tolerated and how the body responds to a single injection into the affected knee1
What treatment is being studied?
- The study is evaluating PCRX-201, an investigational intra-articular (IA) injection that is given directly into the knee joint
- How it works: PCRX-201 is being studied to see if it can reduce pain and inflammation in the knee caused by osteoarthritis
- How it’s given: Participants receive one injection of PCRX-201 at a specific dose level1
What will happen during the study?
- In Part 1, small groups of participants up to a maximum of 24 total will each receive one of three increasing doses of PCRX-201. Safety data from each group will be reviewed before moving to a higher dose1
- In Part 2, up to 105 additional participants will be enrolled to further evaluate the selected doses. Some may receive PCRX-201 alone, while others may receive PCRX-201 after a small steroid pretreatment. Each participant will have one injection and will be followed closely for safety assessments, clinic visits, and lab tests throughout the study period1
- The study is measuring the safety and tolerability of PCRX-201. Researchers will track the number and type of any side effects that occur after a single knee injection of PCRX-2011
How can I learn more?
Study contact information is not available at this time.
Recruitment Locations
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