NCT05864261已完成4 期
A Randomized, Blinding, Single-dose, Positive-drug Parallel Control Study to Compare the Pharmacokinetics Following Administration of JT1801 and Darbepoetin Alfa Injection (NESP®) in Chinese Healthy Adult Volunteers
Yi Fang1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy adult male subjects.
- •Age of 18 to 55 years, inclusive.
- •Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
- •Subject who agree to practive effective barrier contraception and avoid sperm donation during the entire study period and through at least 3 months after the last dose of study drug.
- •Subject who provided written informed consent voluntarily after being fully informed of the study.
- •Subject who is able to communicate well with the investigator and participate in the whole study process according to protocol.
排除标准
- •During the screening period, vital signs measurement, physical examination, laboratory examination (blood routine, reticulocyte, urine routine, blood biochemistry, coagulation function, anemia, transferrin saturation, IgE detection), B-ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant.
- •History of chronic disease or serious disease in cardiovascular, liver, kidney, biliary tract, respiratory, blood, lymphatic, endocrinological, immunologic, psychiatric, neuromuscular, gastrointestinal system within three years.
- •Have a history of specific allergies (e.g. hives) or are allergic (e.g. are known to be allergic to two or more drugs), or have a history of allergy to this ingredient or to EPO drugs.
- •Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
- •Subject with severe psychological or mental illness.
- •Subject with a previous history of tumors.
- •The investigator considers that there are other medical conditions that may affect the study results and the safety of the subjects.
- •Subject who had surgery within 6 months prior to screening period that the investigators determined would affect drug absorption, distribution, metabolism, or excretion, or who planned to have surgery during the study period.
- •Subject who have received other biologics within 6 months.
- •Those with a history of drug abuse (including the use of various narcotic drugs and psychotropic substances for non-medical destinations) or positive drug abuse screening (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.) before the test.
- •Positive for any of the virological tests, including human immunodeficiency virus, hepatitis C antibody, hepatitis B surface antigen, and treponema pallidum antibody.
- •Subjects who have donated blood or lost blood from other reasons within 6 months prior to screening with a total of 400mL or received blood transfusions or used blood products.
- •Has a history of alcohol abuse within 1 year prior to screening, whereby drink more than 2 units of alcohol per week on average (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or alcohol breath test results greater than 0.0mg/100 ml.
- •In the past year, the average daily consumption of excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ≈250mL).
- •Those who smoked > 5 cigarettes per day within 3 months before screening or could not refrain from smoking during the test.
- •Those who have used any drugs (prescription drugs, over-the-counter drugs, vitamins, Chinese herbal medicines, health supplements) within 30 days before enrollment.
- •Those who have used systemic glucocorticoids within 3 months before enrollment.
- •Those who have participated in other clinical trials within 3 months before enrollment.
- •Those who cannot tolerate venipuncture or have a history of needle sickness and blood sickness.
- •Those who have special requirements for diet and cannot accept a unified diet.
- •Subjects who received the vaccine within 3 months prior to the first dosing, or plan to be vaccinated during the study or within 1 week after the last dosing.
- •Those with a low probability of enrollment or poor adherence (such as frailty, physical exhaustion, dehydration or malnutrition, etc.) according to the judgment of the investigator.
研究组 & 干预措施
JT1801
Experimental
干预措施: JT1801 60ug (Drug)
NESP
Active Comparator
干预措施: NESP 60ug (Drug)
结局指标
主要结局
AUC0-t
时间窗: Pre-dose and after dose 20 days
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-t
AUC0-∞
时间窗: Pre-dose and after dose 20 days
PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-∞
次要结局
- TEmax(Pre-dose and after dose 15 days)
- Emax(Pre-dose and after dose 15 days)
- AUEC0-t(Pre-dose and after dose 15 days)
- ΔEmax(Pre-dose and after dose 15 days)
- ΔAUEC0-t(Pre-dose and after dose 15 days)
研究者
Yi Fang
Professor of Pharmacy
Peking University People's Hospital
研究点 (1)
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