A Randomized, Open, Parallel, Phase I Clinical Trial Comparing the Pharmacokinetics of MG-K10 Humanized Monoclonal Antibody in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pharmacokinetic: the maximum concentration (Cmax)
研究概览
简要总结
Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults
详细描述
Objectives of the Study
Main objective: To compare the pharmacokinetics of MG-K10 after a single subcutaneous injection in healthy Chinese adult subjects.
Secondary objectives: To evaluate other pharmacokinetic (PK) parameters of MG-K10 after a single subcutaneous injection; The safety and tolerability of a single subcutaneous injection of MG-K10 in healthy Chinese adult subjects were evaluated. To evaluate the immunogenicity of MG-K10 in healthy Chinese adult subjects.
design: The number of cases in this trial was set as 30 cases in test drug (T) group and 30 cases in control drug (R) group, and a total of 60 subjects were enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants signed the informed consent form before the study, and fully understood the content, process and possible adverse reactions of the study; Volunteer to participate and be able to complete the study in accordance with the protocol requirements.
- •Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive) at the time of signing the informed consent form;
- •During the screening period, the body weight of male volunteers was ≥50 kg; Body weight of women ≥45 kg, and body weight of men and women must not exceed 80 kg (including 80 kg); Body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the boundary value;
- •From the date of signing the informed consent to 6 months after the end of the trial, the volunteers (including male volunteers) had no plans to have children and voluntarily took effective non-drug contraceptive measures, and had no plans to donate sperm or eggs.
排除标准
- •Have any clinically serious disease history or are currently suffering from related diseases, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system (such as asthma, etc.), urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system and other systems; Have any disorders such as coagulopathy (e.g. hemophilia) or a history of haemorrhagic diseases such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; Patients with severe ocular diseases or acute ocular inflammation (conjunctivitis, blepharitis, keratitis, etc.), dry eye or pruritus; Have herpes virus infection;
- •Those who have participated in and used the trial drug;
- •Lactating and pregnant women, or women of childbearing age volunteers with positive blood pregnancy test;
- •Had a history of dizzy with needles and blood; Or patients with orthostatic hypotension；
- •Patients who had used immunosuppressant or immunopotentiator within 3 months before drug administration;
- •There are birthmarks, scars, tattoos, open wounds at the administration site (around the umbilical cord);
研究组 & 干预措施
MG-K10 humanized monoclonal antibody injection (prefilled syringe)
single injection
干预措施: MG-K10 humanized monoclonal antibody injection (prefilled syringe) (Drug)
MG-K10 humanized monoclonal antibody injection
single injection
干预措施: MG-K10 humanized monoclonal antibody injection（Penicillin bottle） (Drug)
结局指标
主要结局
Pharmacokinetic: the maximum concentration (Cmax)
时间窗: 57 days
Concentration and exposure
Pharmacokinetic: area under the curve of o~t
时间窗: 57 days
Concentration and exposure
Pharmacokinetic: area under the curve of o~∞
时间窗: 57 days
Concentration and exposure
次要结局
- Safety evaluation index(57 days)