Safety and Drug Behavior Study of AVD275 Injection for Knee Osteoarthritis Phase 1 Trial with Single-Dose Injections at Varying Levels

What this Trial Is About

Researchers are studying the safety, drug levels, and distribution of AVD275, an injectable form of celecoxib, in patients with osteoarthritis of the knee. This phase 1 trial evaluates a single injection given at three different doses to understand how the drug behaves in the body and its safety profile over time. Participants will receive one injection of AVD275 into the affected knee joint at either a low, middle, or high dose. The study will follow a sequential order of dosing, with each participant monitored for 24 weeks. During this time, they will attend ten clinical visits to receive assessments and monitoring. Participants will be asked to attend regular visits for safety checks and to monitor any side effects that occur during the 24-week period. Researchers will track treatment-emergent adverse events as the primary outcome. The study involves detailed monitoring through clinical visits to ensure participant safety and to gather information on drug concentration and effects.

Study to Assess the Safety and Pharmacokinetics of AVD275 Injection in Patients With Osteoarthritis of the Knee