Single Center Comparative Double Blind Randomized Clinical Study of Pharmacokinetics, Tolerance and Safety of Single Subcutaneous Injection of BCD-057 (JSC "BIOCAD", Russia) and Humira in Healthy Volunteers
概览
- 阶段
- 1 期
- 干预措施
- Adalimumab (BCD-057)
- 疾病 / 适应症
- Healthy
- 发起方
- Biocad
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.
详细描述
This is single center comparative double blind randomized clinical study of pharmacokinetics, tolerance and safety of single subcutaneous injection of BCD-057 (CJSC BIOCAD, Russia) and Humira in healthy volunteers. The purpose of the study is to demonstrate that BCD-057 is equivalent to Humira in terms of pharmacokinetics, tolerability and safety after single subcutaneous injection in healthy volunteers. The study will enroll 94 healthy volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive BCD-057; volunteers from the second group will receive Humira. Both study and reference drug will be used at the standard dose of 40 mg.
研究者
入排标准
入选标准
- •subject has provided informed consent;
- •male gender;
- •18 - 45 years of age inclusively;
- •a body mass index (BMI) between 18,5 and 30 kg/m2;
- •absence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis;
- •parameters of complete blood count, blood biochemistry and urinalysis do not exceed reference values, which are used at Study site laboratory. Evaluation of required laboratory parameters must be performed within 14 days before randomization;
- •normal hemodynamic parameters: systolic BP 100 - 139 mm Hg, diastolic BP - 60 - 90 mm Hg, heart rate - 60 - 90 b/min;
- •ECG results are normal for this age group;
- •absence of chronic infections (HIV, syphilis, hepatitis В or С) and chronic inflammation;
- •absence of active or latent tuberculosis;
排除标准
- •history of adalimumab use or any other TNF inhibitors;
- •known severe allergy (anaphylaxis or multidrug intolerance);
- •known intolerance of monoclonal antibodies or any other excipients of BCD-057/Humira;
- •major surgery within 30 days before ICF signing;
- •presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis.
- •infections which required hospitalization, parenteral anti-infectives within 6 months before randomization;
- •positive results of tests for HIV-1 and HIV-2 antibodies, positive Hbs-Ag, HBc IgM, total antibodies against HCV, positive results of RPR-test;
- •more than 4 episodes of acute respiratory infection within 6 months before randomization;
- •any malignancy (present or history);
- •tuberculosis, including latent forms;
研究组 & 干预措施
BCD-057 group
BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
干预措施: Adalimumab (BCD-057)
Humira group
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
干预措施: Adalimumab (Humira)
结局指标
主要结局
Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira
时间窗: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
时间窗: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
次要结局
- Half-life Period of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira(0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)
- Time to Reach Maximum Concentration of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira(0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)
- Volume of Distribution of Adalimumab After Single Administration of BCD-057/Humira(0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)
- Elimination Rate Constant of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira(0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.(0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)
- Clearance of Adalimumab After Single Subcutaneous Injection of BCD-057/ Humira(0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose)