Multi-center, Randomized, Open-Label, 2-Arm Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 Administered Subcutaneously Via Prefilled Syringe or Autoinjector in Healthy Adult Volunteers (ALVOPAD PEN)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve AUC0-inf
研究概览
简要总结
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)
详细描述
This study is designed as a multi-center, randomized, open-label, 2-arm parallel study of AVT02 administered via a PFS either manually via an autoinjector, in healthy adult subjects.
A total of 204 subjects will be recruited into this study and will be randomly assigned with a ratio of 1:1 to receive either AVT02 manually or via autoinjector. As the study is open-label, both the site staff and the subjects themselves will know which treatments are being administered.
The study consists of a screening period, admission and treatment period, assessment period and end of study (EOS) 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, tolerability and immunogenicity assessments will be performed according to the study schedule (Table 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.
An EOS visit will occur at study Day 64 for final study assessments. The EOS visit will also be the early termination visit if required (to be completed within 7 days of early termination wherever possible).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •To be eligible for study entry, subjects must satisfy all of the following criteria:
- •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: 18.5 to 32.0 kg/m2;
- •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 (BP) of ≤150 mmHg and diastolic BP 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;
- •Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
- •Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
- •Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
- •Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
- •Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;
排除标准
- •To be eligible for study entry, subjects must satisfy all of the following criteria:
- •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: 18.5 to 32.0 kg/m2;
- •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 (BP) of ≤150 mmHg and diastolic BP 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;
- •Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
- •Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
- •Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
- •Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
- •Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;
研究组 & 干预措施
AVT02 100mg/mL in PFS
Prefilled Syringe Arm
干预措施: Adalimumab (Drug)
AVT02 100mg/mL in Autoinjector
Autoinjector Arm
干预措施: Adalimumab (Drug)
结局指标
主要结局
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-t) of AVT02 given in PFS and AVT02 given in autoinjector
Maximum serum concentration
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 given in PFS and AVT02 given in autoinjector
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 given in PFS and AVT02 given in autoinjector
次要结局
- Pain, Tenderness, Erythema and Swelling(From baseline to day 64)
- Anti Drug Antibodies (ADRs)(From baseline to day 64)
- Adverse Events(Baseline to day 84)