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

Phase 1

Completed

Conditions: Osteoarthritis of the Knee

Interventions: Drug: TLC599

Registration Number: NCT02803307

Lead Sponsor: Taiwan Liposome Company

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 mg TLC599	TLC599	6 mg DSP with 50 μmol PL
12 mg TLC599	TLC599	12 mg DSP with 100 μmol PL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	up to 12 weeks after dosing	Number of participants with at least one TEAE

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): MacKay Memorial Hospital
🇨🇳
Taipei, Taiwan
Taipei Medical University Hospital
🇨🇳
Taipei, Taiwan
Taipei Veterans General Hospital
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Taipei, Taiwan