NCT02472912已完成1 期
Single Center, Randomized, Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira, Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of adalimumab.
研究概览
简要总结
Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.
详细描述
This is a single-center, randomized, double-blind, 3-way parallel study in 270 healthy adult male and female subjects. During this study, the PK bioequivalence of BMO-2, containing 40 mg adalimumab, will be compared to EU licensed Humira® (EU-Humira® ) (40 mg) and US licensed Humira® (US-Humira® ) (40 mg).
Randomization will be stratified by body weight (weight categories of 60.0-79.9 kg and 80.0-95.0 kg). After randomization, subjects will receive one of the following treatments: a single sc injection of 40 mg BMO-2, an equivalent sc injection of EU-Humira® (40 mg), or an equivalent sc injection of US-Humira® (40 mg).
Volunteers participation in the study is expected to finish with the follow-up visit, scheduled 70 days after the injection of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight: 60.0-95.0 kg.
- •Body mass index (BMI) : 19.0-30.0 kg/m2, inclusive
- •Medical history without major pathology.
- •Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg.
- •Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology
- •Nonsmoker or light smoker
- •Ability and willingness to abstain from alcohol from 48 h prior to drug administration and 48h prior to ambulatory visits, and during the stays in the clinical research center until discharge from the in-house period.
- •Fertile males and females participating in heterosexual sexual relations:willingness to use adequate contraception from screening until 90 days after the follow-up visit
- •Females must not lactate and must have a negative pregnancy test at screening and at admission
- •Differentiation of leukocytes, platelet count, hematocrit and hemoglobin results within the reference ranges. Minor deviations considered to lack any clinical relevance by the Principal Investigator can be accepted.
- •All other values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator.
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- •History of relevant drug and/or food allergies.
- •Hypersensitivity to Humira® or its constituents.
- •Known history of previous exposure to anti TNF-alpha molecules.
- •Any past or concurrent medical conditions potentially increasing the subject's risks. Examples of these include medical history with evidence of clinically relevant pathology (e.g., malignancies, demyelinating disorders).
- •Presence of chronic obstructive pulmonary disease (COPD). Asthma in the childhood is allowed
- •Any current active infections, including localized infections, or any recent history
- •Treatment with non-topical medications (including over the counter medication, and herbal remedies such as St. John's Wort extract) within 7 days prior to study drug administration, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen, which may be used throughout the study.
- •History of active tuberculosis or presence of active or latent tuberculosis.
- •Having resided or traveled in regions where tuberculosis and mycosis are endemic within 90 days before screening, or who intend to visit such a region during the period of 3 months after dosing.
- •Having received live vaccines during the past 4 weeks before screening or have the intention to receive vaccination during the study.
- •Participation in a drug study within 60 days or 5 half-lives of the previous drug (if known), whichever is longer, prior to drug administration
- •Donation of more than 500 mL of blood within 8 weeks prior to drug administration.
- •History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- •Positive urine drug screen (opiates, methadone, cocaine, amphetamines (including XTC or metamphetamines), cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants) and positive alcohol breath test.
- •Positive screen on Hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus 1/2 antibodies (HIV).
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of adalimumab.
时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.
次要结局
- Frequency of Adverse Events(Up to 71 days.)
- Safey variable - Tolerability (injection site reactions)(Predose and 1, 2, 3, 7, 9, 36, and 71 days post subcutaneous injection.)
- Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)(Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection.)
研究者
研究点 (1)
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