A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of GNR-086 and Ilaris® After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AO GENERIUM
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.
详细描述
GNR-086 (canakinumab) is being developed as a biosimilar to the drug Ilaris®, a lyophilisate for the preparation of solution for subcutaneous administration.
Canakinumab is a recombinant human monoclonal antibody against human interleukine-1β that belongs to the immunoglobulin G1/k (IgG1/k) isotype subclass.
This study is intended for a comparative study of the safety, pharmacokinetics and pharmacodynamics of the drug GNR-086 and the reference drug Ilaris® for the purpose of registration of the drug - GNR-086 (JSC GENERIUM, Russia), 150 mg, lyophilisate for the preparation of solution for subcutaneous administration in the Russian Federation. The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form. The study included a screening period, single administration of study/comparator drug and a follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1 to the study drug and comparator drug. 105 patients (53 to the study drug group and 52 to the comparator drug group) were randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Written informed consent to participate in the study, obtained from the volunteer before the start of any procedures related to the study;
- •Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form;
- •Verified diagnosis "healthy" (the diagnosis "healthy" is established on the basis of a detailed medical history, in the absence of deviations from normal values during a clinical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory data studies, results of electrocardiography and fluorography);
- •Body weight from 50 to 85 kg, body mass index from 18.5 to 28 kg/m2, inclusive.
- •Agreement to adhere to adequate methods of contraception during the entire period of participation in the study or for 3 months after administration of the study or reference drug in case of early termination of participation in the study.
排除标准
- •Severe chronic diseases, history of seizures;
- •Acute infectious diseases less than 4 weeks before administration of the study or reference drug;
- •Any history of chronic or recurrent infectious diseases;
- •History of tuberculosis;
- •Vaccination with any vaccine within 3 months before the administration of the study or reference drug or planned for the period of the volunteer's participation in the study;
- •Compounded allergy history; history of hypersensitivity to the active substance or other components of the study or reference drug;
- •Pregnancy or breastfeeding period;
- •Special lifestyle (work at night, extreme physical activity);
- •Deviations of vital signs: systolic pressure less than 100 mm Hg. Art. or more than 130 mm Hg. Art.; diastolic pressure less than 60 mm Hg. Art. or more than 90 mm Hg. Art.; heart rate less than 60 beats/min or more than 90 beats/min;
- •Dehydration due to diarrhea, vomiting, or other cause within 24 hours prior to administration of the study or reference drug;
- •Taking prescription medications within 28 days or 5 half-lives (whichever is longer) or taking over-the-counter medications/dietary supplements within 14 days prior to study or reference drug administration (occasional use of paracetamol at any time prior to study drug administration is acceptable) or reference drug);
- •Blood donation or blood loss (450 ml of blood or more) less than 3 months before the administration of the study or reference drug and/or blood donation in any quantity planned for the period of the volunteer's participation in the study;
- •Participation in clinical trials of medicinal products (less than 3 months or 5 half-lives from the study drug, whichever is longer) before administration of the investigational or reference drug of this study;
- •Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol or 325 ml of beer), or information about a history of alcoholism, drug addiction, or drug abuse;
- •Positive test for the presence of alcohol in exhaled air;
- •Smoking more than 5 cigarettes per day for 3 months before this study;
- •Positive urine test for the content of narcotic and potent drugs;
- •Positive test for hepatitis B, C, HIV or syphilis;
- •Any surgical interventions planned during the period of participation in the study;
- •Unwillingness or inability to comply with the requirements of this protocol.
结局指标
主要结局
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
时间窗: Day 120
Analysis of equivalence of area under concentration-time curve from time 0 (predose) extrapolated to infinity (AUC(0-∞) of GNR-086 and Ilaris®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
时间窗: Day 120
Analysis of equivalence of Cmax of GNR-086 and Ilaris®
次要结局
- Pharmacodynamics: interleukin-1β (IL-1β)(Day 120)
- Proportion of volunteers with adverse events (AE)(Day 120)
- Immunogenicity(Day 120)
- Pharmacodynamics: Area Under IL-1β Curve (AUC)(Day 120)