NCT02803307

Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed description

Protocol No: TLC599A1001 Name of Finished Product: TLC599 Title of Study: A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee. Study duration: The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	TLC599	Single dose via intra-articular injection

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-06-16
• Last updated: 2022-05-06
• Results posted: 2022-05-06

Locations

3 sites across 1 country: Taiwan