A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2
研究概览
简要总结
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
- •Screening pain criteria sufficient as assessed by WOMAC and VAS scores
- •Ability to read and understand the informed consent
排除标准
- •Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
- •Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- •Body mass index >40
- •Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
- •History of malignancy within the last 5 years
- •Participation in a clinical research trial within 12 weeks prior
- •Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
- •Effusion of the target knee requiring aspiration within 3 months
- •Use of electrotherapy or acupuncture for OA within 4 weeks
- •Significant and clinically evident misalignment of the target knee
- •Any known active infections
- •Any chronic condition that has not been well controlled for a minimum of 3 months
研究组 & 干预措施
SM04690, 0.03mg/2mL
Single, intra-articular injection of SM04690, 0.03mg/2mL
干预措施: SM04690, 0.03mg/2mL (Drug)
SM04690, 0.07mg/2mL
Single, intra-articular injection of SM04690, 0.07mg/2mL
干预措施: SM04690, 0.07mg/2mL (Drug)
SM04690, 0.23mg/2mL
Single, intra-articular injection of SM04690, 0.23mg/2mL
干预措施: SM04690, 0.23mg/2mL (Drug)
Placebo
Single, intra-articular injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2
时间窗: during 12 weeks
Additional safety assessment of bone loss as measured by CT of the knee
时间窗: during 24 weeks
Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests
时间窗: during 24 weeks
次要结局
- Change from baseline of cartilage volume and thickness as measure by MRI(during 24 weeks)
- Change from baseline of biomarkers of cartilage synthesis and cytokines(during 24 weeks)
- Change from baseline per physician global assessment of disease scale(during 24 weeks)
- Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS)(during 24 weeks)
- Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale(During 24 weeks)
- Change from baseline in joint space width as measured by X-ray(during 24 weeks)