A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.
详细描述
This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Japanese participants aged 20 to 80 years at screening
- •A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
- •Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).
排除标准
- •Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
- •Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
- •Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
- •Malalignment >10° in the target knee (varus/valgus)
研究组 & 干预措施
placebo
干预措施: Placebo (Drug)
LNA043
LNA043
干预措施: LNA043 (Drug)
LNA043
LNA043
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to Day 22
To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
次要结局
- Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration(0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose)
- Observed maximum serum concentration of LNA043(0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose)
- Number of participants with anti-LNA043 antibodies in serum(Day 1 (pre-dose), 4, 8, 15, 22)