NCT05807529

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Orient Europharma Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	2ccPA	2-carba-cyclic phosphatidic acid (2ccPA) is a first-in-class phospholipase autotaxin (ATX) inhibitor that may act as a disease-modifying drug and may relieve OA associated symptoms. Phase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1 Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29
DRUG	Placebo	Phase I: 2 dose cohorts (4800μg, 7200μg) single dose at Day 1 Phase II: 3 dose cohorts (2400μg, 4800μg, 7200μg) multiple dose at Day 1, 15, 29

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-04-11
• Last updated: 2024-03-21

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study