NCT03005873

Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients

A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed description

Protocol No: TLC599A2003 Name of Finished Product: TLC599 Title of Study: A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee. Study duration: The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	TLC599 LD group	Single dose via intra-articular injection
DRUG	Normal Saline	Single dose via intra-articular injection
DRUG	TLC599 HD group	Single dose via intra-articular injection

Timeline

• Start date: 2017-03-16
• Primary completion: 2018-07-04
• Completion: 2018-07-04
• First posted: 2016-12-29
• Last updated: 2024-04-22
• Results posted: 2024-04-22

Locations

13 sites across 2 countries: Australia, Taiwan