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

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.

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.

Inclusion Criteria:

1. Male or female subjects, at least 20 years of age
2. Documented diagnosis of OA of the knee for at least 6 months
3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale
4. VAS score of ≥ 4 at baseline

Exclusion Criteria:

1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline
2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline
3. History of rheumatoid arthritis or other autoimmune disease
4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing
5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee
6. Concurrent systemic active or uncontrolled infectious disease
7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix)
8. History of acquired or congenital immunodeficiency diseases
9. Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia
10. Stroke or myocardial infarction within 3 months prior to the screening visit
11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit
12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period
13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space
14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components