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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: TLC599


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, at least 20 years of age Documented diagnosis of OA of the knee for at least 6 months At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale VAS score of ≥ 4 at baseline Exclusion Criteria: Subjects who received systemic corticosteroids for the last 30 days prior to baseline Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline History of rheumatoid arthritis or other autoimmune disease Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee Concurrent systemic active or uncontrolled infectious disease 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) History of acquired or congenital immunodeficiency diseases Platelet count < 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia Stroke or myocardial infarction within 3 months prior to the screening visit 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 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 Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 mg TLC599<br>6 mg DSP with 50 μmol PL | Drug: TLC599<br>* Single dose via intra-articular injection<br>|
| Experimental: 12 mg TLC599<br>12 mg DSP with 100 μmol PL | Drug: TLC599<br>* Single dose via intra-articular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Number of participants with at least one TEAE | up to 12 weeks after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DSP, osteoarthritis of the knee, TLC599, Dexamethasone