NCT03583346已完成1 期
A Phase Ib, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injections of M6495 (Anti-ADAMTS-5 Nanobody) in Participants With Symptomatic Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Occurrences of Injection Site Reactions
研究概览
简要总结
The study will be conducted in participants with symptomatic knee OA to explore the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of MAD of M6495.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kellgren Lawrence (KL) radiological Grade of 2 to 4 in the target knee
- •Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore of greater than or equal to (>=) 40 out of 100 in the target knee at screening
- •Primary or post-traumatic femorotibial OA according to American College of Rheumatology clinical and radiographic criteria
- •Have completed at least 4 days of the participant 7-day diary in the period from Day -8 to Day 1
- •Can give signed informed consent
- •Other protocol defined inclusion criteria could apply
排除标准
- •History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening
- •Intention of having major knee surgeries or total knee replacement during the time frame of this study in either knee
- •Secondary OA in target knee joint because of joint dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis, or calcium pyrophosphate deposition disease
- •Any known active systemic infection, including infection that might compromise the immune system such as human immunodeficiency virus, or hepatitis B or C
- •History of myocardial infarction or cerebrovascular event within 6 months prior to screening, or current active angina pectoris, symptomatic heart failure, seizures, untreated hypertension, gastrointestinal bleeding, or any other significant medical condition in the Investigator's opinion
- •History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix, unless considered cured >= 5 years
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
M6495
Experimental
干预措施: M6495 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrences of Injection Site Reactions
时间窗: Day 1 up to Day 43
Occurrences of Treatment-emergent Adverse Events (TEAEs), Treatment-related AEs and Serious AEs (SAEs)
时间窗: Day 1 up to Day 106
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
时间窗: Day 1 up to Day 106
Number of participants with clinically significant change from baseline will be reported.
次要结局
- Maximum Observed Serum Concentration (Cmax) of M6495(Day 1 up to Day 106)
- Accumulation Ratio for Cmax (Racc [Cmax]) of M6495(Day 1, 15 and 29)
- Immunogenicity of M6495 as Assessed by Antidrug Antibodies (ADA) Assays(Day 1 up to Day 106)
- Dose Normalized Maximum Serum Concentration (Cmax/Dose) of M6495(Day 1 up to Day 106)
研究者
研究点 (1)
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