A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Change From Baseline in WOMAC Pain Subscale at Week 12
研究概览
简要总结
This trial is a Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.
详细描述
Protocol No: TLC599A2003 Name of Finished Product: TLC599
Title of Study:
A Phase IIa, Randomized, Double blinded, Placebo controlled, Dose finding Study for Single dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee.
Study duration:
The trial will last around 27 weeks including a 21-day screening period and a 24-week follow-up period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, at least 50 years of age.
- •Documented diagnosis of OA of the knee for at least 6 months
- •The study knee has OA with Grade 2 to 3 severity based on the Kellgren Lawrence grades
- •Patients with patient related visual analogue scale (VAS) score of 5.0 to 9.0 at baseline.
- •Willing and able to comply with study procedures and provide written informed consent.
排除标准
- •Patients who received systemic corticosteroids within the last 30 days prior to dosing.
- •Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.
- •Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.
- •Documented history and confirmed autoimmune disease
- •History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee
- •History of infective arthritis
- •Unstable study knee joint
- •Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.
- •A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit
- •Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient
- •Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.
- •Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.
- •Abnormalities of laboratory parameters as described below will qualify for exclusion:
- •hemoglobin < 8 g/dL;
- •total white blood cell count < 4000/ µL;
- •serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase > 2 times upper limit of normal (ULN) for the laboratory reference ranges;
- •serum creatinine > 2 times ULN for the laboratory reference range;
- •serum uric acid > ULN for the laboratory reference range;
- •prothrombin time/International Normalized Ratio > ULN for the laboratory reference range.
- •Contraindication to undergoing magnetic resonance imaging (MRI)
研究组 & 干预措施
TLC599 LD group
12 mg DSP with 100 µmol PL (1.0 mL)
干预措施: TLC599 LD group (Drug)
TLC599 HD group
18 mg DSP with 150 µmol PL (1.5 mL)
干预措施: TLC599 HD group (Drug)
Placebo group
1.5 mL normal saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change From Baseline in WOMAC Pain Subscale at Week 12
时间窗: Baseline, Week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale consist of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. The total score of the pain subscale for each patient is normalized and expressed on a 0 to 4 scale. Higher scores represent higher levels of pain (worse outcome), whereas lower scores represent lower levels of pain (better outcome). Missing data were imputed.
次要结局
未报告次要终点