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A Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Symptomatic Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:
A Phase I-II, Dose-escalation, Double-blinded, Placebo-controlled, and Dose-finding Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Osteoarthritis of the Knee

Clinical Trial Summary

This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and 7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee.

Clinical Trial Description

Osteoarthritis (OA) is a degenerative disease frequently associated with symptoms such as inflammation, stiffness, muscle weakness, joint swollen and joint pain. 2-carba-cyclic phosphatidic acid (2ccPA) is the derivative of natural occurring phospholipid mediator, cyclic phosphatidic acid (cPA). Previous studies suggested that 2ccPA inhibits inflammation and may relieve the pain caused by osteoarthritis. This phase I/II study aims to evaluate the safety of single doses of 2ccPA 4,800 μg and7,200 μg (Phase I), as well as the safety and efficacy of multiple doses of 2ccPA (Phase II) in patients with osteoarthritis (OA) of the knee. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05807529
Study type Interventional
Source Orient Europharma Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 3, 2022
Completion date December 2024
View Details
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