A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tlag
研究概览
简要总结
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
详细描述
Rationale for the Study:
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.
Study Design:
This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.
Four Avonex IM injections will be administered in this study. Due to the long-term use of Avonex by MS patients, a multiple-dose PK/PD study is necessary in order to provide adequate information to evaluate changes in drug concentrations over time in Chinese healthy subjects. Serum levels of interferon beta in Caucasian healthy volunteers have been shown to peak between 3 and 15 hours after administration of Avonex IM at the dose being used in this study and have been shown to decline at a rate consistent with a 10-hour elimination half-life; therefore, accumulation of interferon beta following multiple weekly Avonex IM injections is not anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Subjects of Chinese origin (at least both maternal and paternal grandparents of Chinese origin).
- •Body mass index (BMI) within the range of 18.5 to 30 kg/m2 (inclusive).
- •All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day
- •History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day
- •Any clinically significant presence (as determined by the Investigator) of cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease.
- •Positive test result for hepatitis C antibody (HCV Ab), or current hepatitis B infection at Screening.
- •Known history of human immunodeficiency virus (HIV).
- •Clinically significant abnormal laboratory values.
- •History of alcohol abuse (as defined by the Investigator), or a positive blood screen test for presence for alcohol at Screening.
- •History of drug abuse (as defined by the Investigator), or a positive urinary screen test for presence of cocaine and morphine.
- •Premalignant and malignant disease.
- •History of clinically significant severe allergic or anaphylactic reactions.
- •Known allergy to any component of the Avonex formulation.
- •History of hypersensitivity or intolerance to prophylactic analgesic medication that would preclude use during the study.
- •Clinically significant abnormal electrocardiogram (ECG) values as determined by the Investigator.
- •Known allergy to interferon beta-1a.
- •Active bacterial or viral infection.
- •Female subjects who are pregnant or currently breastfeeding.
- •Previous participation in another investigational drug study within the last 1 month or 7 half-lives, whichever is longer, or previous participation in this study.
- •Treatment with any prescription medication within 14 days of Day
- •Treatment with any over-the-counter products within the 14 days prior to Day
- •Donation of blood (500 mL or greater) within 56 days prior to Day
- •Inability to comply with study requirements
研究组 & 干预措施
Avonex
4 weekly injections of Avonex (IM)
干预措施: Avonex (Drug)
结局指标
主要结局
Tlag
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Cmax
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Tmax
时间窗: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-t
时间窗: Participants will be followed for the duration of the study; and expected 2 months
AUC 0-infinity
时间窗: Participants will be followed for the duration of the study; and expected 2 months
T 1/2
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Ka
时间窗: Participants will be followed for the duration of the study; and expected 2 months
T 1/2ab
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Kcl
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Kir
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Emax
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Tmax(E)
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Eauc
时间窗: Participants will be followed for the duration of the study; and expected 2 months
Induction ratio
时间窗: Participants will be followed for the duration of the study; and expected 2 months
T1/2 return to baseline
时间窗: Participants will be followed for the duration of the study; and expected 2 months
次要结局
- Number of Adverse Events as a measure of safety and tolerability(Participants will be followed for the duration of the study; and expected 2 months)
- Number of Serious Adverse Events as a measure of safety and tolerability(Participants will be followed for the duration of the study; and expected 2 months)
- Changes in lab assessments(Participants will be followed for the duration of the study; and expected 2 months)
- Changes in vital signs(Participants will be followed for the duration of the study; and expected 2 months)
- Changes in physical examinations(Participants will be followed for the duration of the study; and expected 2 months)
- Changes in ECGs(Participants will be followed for the duration of the study; and expected 2 months)