A Randomized, Double-blind, Placebo-controlled Dose Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of EP-9001A Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number and severity of Adverse Events，MTD
研究概览
简要总结
Nerve Growth Factor（NGF）plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.
详细描述
Nerve Growth Factor（NGF）plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.
The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.
The initial dose of the study was set as 1 mg, and the doses were escalated sequentially in the order of 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 25 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female Chinese volunteers ≥18 and ≤45 years of age at the screening visit;
- •Body weight ≥ 45.0 kg for female subjects and ≥ 50.0 kg for male subjects with a body mass index (BMI) between 19.0 and 26.0 kg/m2( including border value);
- •Subjects during the trial (female subjects from 14 days before dosing, male subjects from dosing) to 3 months after the end of the trial without fertility or sperm/egg donation plan and voluntarily take effective physical contraception measures;
- •According to the results of physical examination, vital signs, ECG and clinical laboratory tests during the screening period, all the test results are normal or abnormal without clinical significance as judged by the investigator;
- •Signed a written informed consent.
排除标准
- •history of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), or a history of drug allergy, or a history of allergy to the test drug ingredients;
- •history of clinical serious diseases and not cured, such as motor (muscle and bone) system, digestive system, respiratory system, genitourinary system, blood (hematopoietic) system, circulatory system, nervous system, mental system, endocrine system, cardiovascular system and metabolic abnormalities;
- •received surgery in the past 3 months or have surgery plan during the trial ;
- •Have used any prescription, over-the-counter or health care products in the past 2 weeks;
- •took more than 10 cigarettes a day or the same amount of tobacco or can not stop tobacco during trial;
- •alcohol breath test positive;
- •History of alcohol abuse within the past 6 months;
- •History of drug abuse, positive results of urine multiple drug tests;
- •Drink excessive tea, grapefruit juice, coffee or caffeinated beverages (an average of more than 8 cups per day, 200 mL per cup) every day in the past 1 month;
- •Participated in other drug clinical trials in the past 3 months, or plan to participate in other clinical trials during this study;
- •Blood loss/blood donation of more than 400 mL in the past 3 months (except for female physiological blood loss), or receiving blood transfusion or use of blood products, or planning to donate blood during the trial or within 1 month after the end of the trial;
- •Vaccinated within the past 1 month
- •positive in Hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, syphilis specific antibody screening;
- •Subjects who are lactating, pregnant or plan to become pregnant or conceive recently;
- •Patients with a history of bone or joint diseases, including but not limited to osteoarthritis, pathological fractures, osteonecrosis, rheumatoid arthritis, neuropathic arthritis, lupus erythematosus or inflammatory joint diseases;
- •Patients with a history of joint-related events, such as total joint replacement (TJR) surgery, meniscus or knee ligament injury (with or without surgical repair) or joint infection, or bone dislocation, hip dislocation, knee dislocation within 1 year before screening;
- •Kellgren-Lawrence grade ≥ 2 in any major joint (shoulder, hip, knee);
- •History of clinically significant peripheral neuropathy, paresthesia, dysesthesia;
- •History of autonomic neuropathy or diabetic neuropathy;
- •The investigator assesses the poor compliance, or the investigator believes that the subject has any other conditions that are not suitable for participating in this clinical study
研究组 & 干预措施
Placebo
Dose-escalation trial
干预措施: placebo (Drug)
EP-9001A
Dose-escalation trial
干预措施: EP-9001A (Drug)
结局指标
主要结局
Number and severity of Adverse Events，MTD
时间窗: Baseline to week 8
All adverse events occurring throughout the study were assessed and graded. the maximum tolerated dose (MTD)
次要结局
- pharmacokinetics of EP-9001A(Baseline to week 8)
- immunogenicity assessed by ADA(Baseline to week 8)