CTRI/2024/09/073894已完成1 期
A randomized phase 1, double-blind, single dose, three-arm, parallel group comparative Pharmacokinetic, Pharmacodynamic, safety, and immunogenicity assessment of BP08 (Tocilizumab) versus US licensed Actemra® and EU approved RoActemra® administration through the Intravenous infusion route in healthy adult male subjects.
CuraTeQ Biologics Private Ltd.1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年9月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Pharmacokinetics : Cmax and AUC0-inf
研究概览
简要总结
Tocilizumab is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure.
BP08 is being developed by Cura TeQ Biologics Private Limited as a Tocilizumab biosimilar to the US licensed -Actemra® and European Union (EU)-approved RoActemra® and it used for the following indications.
Rheumatoid Arthritis (RA)
Giant Cell Arteritis (GCA)
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Systemic Juvenile Idiopathic Arthritis (SJIA)
Cytokine Release Syndrome (CRS)
This study is aimed to compare the pharmacokinetics (PK) of BP08 with EU-approved RoActemra® and US licensed Actemra® in healthy male adult subjects using randomized phase 1, double blind, single dose, three-arm, parallel, comparative assessment of PK, PD safety, and immunogenicity of BP08 (Tocilizumab) versus US licensed Actemra® and EU approved-RoActemra® in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy, adult, male human subjects aged between 18 and 45 years (both inclusive) at the time of signing informed consent.
- •Capable and willing to providing written informed consent to the study requirements.
- •Have systolic blood pressure ≤140 and ≥90 mmHg, diastolic blood pressure ≤90 and ≥60 mmHg, and a heart rate ≥50 and ≤100 beats per minute at Screening/Day 1 (admission to study center).
- •Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, radial pulse rate, body temperature, including respiratory rate) as judged by the Investigator.
- •Subjects who are considered healthy as determined by clinically acceptable findings of haematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram.
- •Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after infusion by agreeing to use (with their female partner) 2 acceptable contraceptives.
- •Willing to stay on study restrictions throughout the study duration.
- •A non-smoker or non-alcoholics.
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative alcohol breath test/Urine Alcohol test.
排除标准
- •Known history of hypersensitivity or allergic reactions to Tocilizumab or any of its excipients and heparin.
- •History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological,psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
- •Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
- •Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
- •Use of prescription or non-prescription (OTC) drugs, including vitamins, herbal and dietary supplements (including St. John’s Wort, grapefruit) within 30 days prior to the dosing of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
- •Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- •Difficulty in blood sampling or difficulty in the accessibility of veins.
- •Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath/urine alcohol done before check-in.
- •Subjects with a history of drug of abuse or positive in urine screen for drug of abuse test at screening or admission.
- •Blood donation within 90 days prior to the commencement of the study and during the study.
- •Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcoholic products within 48 hours prior to admission.
- •Consumption of grapefruit, grapefruit juices within 72.00 hours prior to admission.
- •Any persons who are: An employee of the Principal Investigator, clinical center, contract research organization (CRO) or Sponsor.
- •A relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.
- •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •Intolerance to direct vein puncture.
结局指标
主要结局
Pharmacokinetics : Cmax and AUC0-inf
时间窗: Various timepoints from day 1 to day 50
次要结局
- Pharmacokinetic endpoints : AUC0-t, Tmax, t½, ƛz, & CL
- Pharmacodynamic endpoints : IL6 levels(Various timepoints from day 1 to day 50)
- Immunogenicity endpoints : Anti-drug antibody, & neutralizing antibody to BP08 (Tocilizumab) , US licensed -Actemra® & EU-approved RoActemra(Various timepoints from day 1 to day 50)
- Safety endpoints: Adverse events, clinical laboratory values, vital signs, physical examinations, & ECG(Throughout study duration)
研究者
Dr Darshankumar Kharadi
Veeda Clinical Research Ltd
研究点 (1)
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