NCT02803307已完成1 期
A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration Trial of TLC599 in Subjects With Osteoarthritis of the Knee
Taiwan Liposome Company3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
6 mg TLC599
Experimental
6 mg DSP with 50 μmol PL
干预措施: TLC599 (Drug)
12 mg TLC599
Experimental
12 mg DSP with 100 μmol PL
干预措施: TLC599 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: up to 12 weeks after dosing
Number of participants with at least one TEAE
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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