A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-articular Dose of the TrkA Inhibitor, GZ389988, in Patients With Painful Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Proportion of patients with adverse events
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in patients with painful osteoarthritis (OA) of the knee.
Secondary Objectives:
To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee.
To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee.
详细描述
Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 84 ± 7 days up to the end-of-study visit.
Total duration for one patient will be up to 17 weeks (up to the end-of-study visit), not including the long term observational safety follow-up by phone call for 12 additional weeks.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Single intraarticular injection of placebo for GZ389988 in the knee joint
干预措施: placebo (Drug)
GZ389988
Single intraarticular injection of GZ389988 in the knee joint
干预措施: GZ389988 (Drug)
结局指标
主要结局
Proportion of patients with adverse events
时间窗: Up to Day 84 after single intraarticular dose of GZ389988
Proportion of patients with serious adverse events
时间窗: 12 additional weeks after day 84 (by phone calls)
次要结局
- Apparent volume of distribution (Vz/F) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Maximum plasma concentration (Cmax) of GZ389988 single dose intraarticular (IA)(24 timepoints up to Day 84)
- Area under the curve from time zero to last quantifiable concentration (AUClast) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Area under the curve (AUC) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Plasma elimination half-life (t1/2z) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Time to peak plasma concentration (tmax) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Time curve from administration to last measurement (tlast) of single dose GZ389988 IA(24 timepoints up to Day 84)
- Apparent total body clearance(CL/F) of single dose GZ389998 IA(24 timepoints up to Day 84)
- Synovial fluid concentrations (if possible) of single dose GZ389988 IA(3 timepoints up to Day 84)
- Change from baseline in WOMAC index (total score)(Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection)
- Change from baseline in WOMAC pain (including WOMAC A1 pain subscores)(Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection)
- Change from baseline in WOMAC stiffness subscore(Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection)
- Change from baseline in WOMAC physical function subscore(Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection)