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A Phase 2, Open Label, PK Study of TLC599 in Subject With Osteoarthritis of the Knee

OSTEOARTHRITIS OF THE KNEE Clinical Trial

Official title:
A Phase 2, Open-label, Pharmacokinetic Study of a Single Intra-articular Administration of TLC599 in Subjects With Mild to Moderate Osteoarthritis of the Knee

Clinical Trial Summary

This study is a multi-center, Phase 2, open-label, 1-period, parallel study with 9 cohorts of subjects with OA of the knee enrolled to receive single-dose of TLC599 or DSP via IA injection and 1 cohort of healthy subjects to receive single-dose of DSP via IV injection.

Clinical Trial Description

This Phase 2, open-label, 1 period, parallel study will enroll 1. approximately 90 subjects to receive a single dose of TLC599 or DSP via IA injection, followed by a PK evaluation period up to 24 weeks and an additional follow-up period of 1 to 5 weeks. Additional subjects may be recruited as needed to achieve at least 10 subjects completing the 1-week blood collection period for each treatment. 2. approximately 12 healthy subjects to recieve a single dose of DSP via IV injection, followed by a PK evaluation period up to 1 week and an additional follow-up period of 1 week. Additional subjects may be recruited as needed to achieve at least 12 subjects completing the 48-hour blood collection period for IV DSP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03754049
Study type Interventional
Source Taiwan Liposome Company
Contact
Status Completed
Phase Phase 2
Start date January 21, 2019
Completion date November 7, 2023
View Details
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