Multicentre, Randomized, Double-Blind, 3-Arm, Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 to EU-approved and US-licensed Humira® Administered as a Single Dose (40 mg Subcutaneous Injection) in Healthy Adult Volunteers (ALVOPA D FIRST)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 3
- 主要终点
- Area under the plasma concentration-time curve AUC0-t
研究概览
简要总结
This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira (US-Humira), when administered as a single 40 mg SC dose.
详细描述
AVT02 is being developed as a biosimilar to Humira. EU-Humira and US-Humira have therefore been selected as the active control groups in this study.
This study is designed as a multi-center, randomised, double-blind, 3-arm parallel study of AVT02 compared to EU-Humira and US-Humira in healthy adult subjects. The study is designed to evaluate the PK, safety and tolerability of AVT02 compared to EU-Humira and US-Humira when administered as a single dose (40 mg) SC injection.
Subjects will be randomly assigned with a ratio of 1:1:1 to receive either AVT02 or EU-Humira or US-Humira on a single occasion on study Day 1. Both the site staff assessing the subjects and the subjects themselves will be blinded to the treatments being administered.
The study consists of a screening period, admission and treatment period, assessment period and end of study visit. Subjects will undertake a screening visit between Day -28 and Day -1 to determine eligibility in the study. Those subjects that meet the eligibility criteria will be admitted to the study site on the evening prior to dosing (Day -1) when continued eligibility will be assessed.
On Day 1 prior to dosing, baseline assessments will be performed. Subjects will then be dosed according to the randomization schedule. Following dosing, PK, safety and tolerability assessments will be performed according to the study schedule (Table 6Table 6). Subjects will remain confined to the study site from Day -1 to Day 3 (48 hours post-dose). Subjects will return to the study site on Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 12, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 and Day 57.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy adult subjects willing to sign a patient information and consent form (PICF) and able to undergo protocol related procedures.
- •Age: 18 to 55 years, inclusive.
- •Body Mass Index (BMI): 18.5 to 32.0 kg/m
- •No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety.
- •Resting supine systolic blood pressure of ≤150 mmHg and diastolic blood pressure of ≤90 mmHg. Other vital signs showing no clinically relevant deviations according to the investigator's judgment.
- •12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
- •Negative urine drug screen and negative alcohol breath test at screening and admission.
- •Exclusion Criteria
- •Subjects will be excluded from the study if one or more of the following criterion are applicable:
- •Evidence of clinically relevant pathology
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) used in study.
- •Known history of previous exposure to adalimumab or other anti TNF-alpha molecules.
- •Subjects with a recent (within 6 months of dosing) infection requiring hospitalisation or intravenous antibiotic use.
- •Subjects with a recent (within 4 weeks of dosing) infection requiring oral or systemic antibiotics.
- •Subject with a history of recurrent or chronic infections.
- •Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB.
- •Having received live vaccines during the 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 Note: Only the few inclusion/exclusion criteria are mentioned here. Subjects will be screened and randomized as per the full list of inclusion and exclusion criteria in the protocol.
排除标准
- 未提供
研究组 & 干预措施
AVT02 100mg/mL
Biosimilar Adalimumab AVT02
干预措施: Adalimumab (Drug)
EU-Humira 100mg/mL
EU Approved Adalimumab originator Humira
干预措施: Adalimumab (Drug)
US-Humira 100mg/mL
US licensed Adalimumab originator Humira
干预措施: Adalimumab (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve AUC0-t
时间窗: From baseline to day 64
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02, US-Humira EU Humira
Maximum serum concentration
时间窗: From baseline to day 64
Venous blood samples will be collected for measurement of serum concentration of AVT02, EU Humira, US-Humira
Area under the plasma concentration-time curve AUC0-inf
时间窗: From baseline to day 64
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-inf) of AVT02, US-Humira EU Humira
次要结局
- Pain, Tenderness, Erythema and Swelling(From baseline to over a 64 day period)
- Anti Drug Antibodies (ADRs)(Baseline to over a 64 day period)
- Neutralizing Antibodies (NAbs)(From screening to day 64.)
- Adverse Events(From screening to day 64.)