A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- SC and IV Arm: Area under the serum concentration-time curve from the pre-dose concentration extrapolated to infinity (AUCinf)
研究概览
简要总结
This is a randomized, Phase I, open-label, single-dose study to evaluate the PK, safety, and tolerability of anifrolumab administered to male and female healthy Chinese participants aged 18 to 55 years. Approximately 24 participants, who fulfill the eligibility criteria, will be administered anifrolumab via SC route or IV route, and participants will be randomized to the two arms in a 1:1 ratio.
详细描述
The purpose of this study is to evaluate the PK, safety, and tolerability of a single dose of anifrolumab subcutaneously or intravenously administered to healthy Chinese participants aged 18 to 55 years. The primary study endpoints are PK standard endpoints. The secondary study endpoints are standard endpoints for safety assessment, including adverse events, serious adverse events, and clinical safety laboratory measurements. The participants must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
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
- •Able to complete the follow-up visit as required by the protocol.
- •Participant must be 18 to 55 years of age (both inclusive), at the time of signature of the ICF.
- •A body mass index of ≥ 18.5 to ≤ 26.0 kg/m2 and body weight of at least 45 kg for females and 50 kg for males at screening.
- •Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
排除标准
- •History of malignancy with some exceptions
- •History of alcohol or drug abuse within the past 2 years.
- •Any significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
研究组 & 干预措施
Subcutaneous
干预措施: Anifrolumab (Drug)
Intravenous
干预措施: Anifrolumab (Drug)
结局指标
主要结局
SC and IV Arm: Area under the serum concentration-time curve from the pre-dose concentration extrapolated to infinity (AUCinf)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (AUCinf will be derived).
SC and IV Arm: Maximum observed serum (peak) concentration (Cmax)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (Cmax will be derived).
SC and IV Arm: Time to reach peak or maximum observed concentration (tmax)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (tmax will be derived).
SC and IV Arm: Area under the serum concentration-time curve from pre-dose concentration to time of last quantifiable concentration (AUClast)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (AUClast will be derived).
SC and IV Arm: half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (t½λz)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (t½λz will be derived).
Bioavailability (F)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (F will be derived).
SC Arm: Apparent total body clearance of drug after extravascular administration (CL/F)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (CL/F will be derived).
SC Arm:Volume of distribution during the terminal phase after extravascular administration (Vz/F)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (Vz/F will be derived).
IV Arm: volume of distribution during the terminal phase after intravenous administration (Vz)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (Vz will be derived).
IV Arm: Apparent total body clearance of drug after intravenous administration (CL)
时间窗: At predefined intervals throughout the study period (From Day 1 to Day 57)
The concentration of anifrolumab in serum will be determined (CL will be derived).
次要结局
- Adverse Event(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Vital Signs of blood pressure(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- 12-lead ECG measurements include heart rate, RR interval, PR interval, QRS duration, and QT interval(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Safety haematology laboratory parameters: WBC, Neutrophils absolute count, RBC, Lymphocytes absolute count, Hb, Monocytes absolute count, HCT, Eosinophils absolute count, MCV, Basophils absolute count, MCH, Platelets, MCHC, Reticulocytes absolute count(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Physical examination of height(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Vital Signs of pulse rate(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Vital Signs of body temperature(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Vital Signs of respiratory rate(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Safety clinical chemistry laboratory parameters: Sodium, CRP, Potassium, ALP, Urea, ALT, Creatinine, AST, Albumin, GGT, Calcium, TBL, Phosphate, Conjugated bilirubin, Glucose, Creatine kinase(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Safety urinalysis laboratory parameters: Glucose Protein, Blood, Microscopy (if positive for protein or blood)(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Physical examination of weight(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))
- Physical examination of general appearance, the lungs, cardiovascular system, and the abdomen(From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks))