Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peak concentration
研究概览
简要总结
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
详细描述
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and after administration.
30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1 ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age of 18-55, healthy volunteers (including the threshold, based on time of signing informed consent form).
- •BMI of 19 to 26 kg/m2 (including the threshold), with male ≥ 50 kg and female ≥ 45 kg.
- •Subjects and their partners agreed never to have children from 2 weeks prior to screening until 6 months after administration and volunteered to use effective contraception, regardless of sperm or oocyte donation plans.
排除标准
- •Allergic to investigational drug or allergic constitution .
- •With difficulty in intravenous administration/blood collection or a history of dizziness from needles and blood.
- •Have substance abuse in the past 5 years or used drugs in the past 3 months prior to screening, or drug tested positive.
- •Smoked an average of >5 cigarettes per day in the 3 months prior to screening or were unable to stop using any tobacco-based products during the study.
- •Consumption of an average of >14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) in the past 3 months prior to screening, or inability to abstain from alcohol during the trial, or positive blood test for alcohol
- •Any drugs that inhibit or induce hepatic CYP3A metabolizing enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to screening.
- •Any use of prescription, over-the-counter or herbal medicines and supplements within 14 days prior to screening
- •Received vaccination within 4 weeks prior to screening or planned vaccination during the study.
- •Consumption of dragon fruit, mango, grapefruit, carambola or food or drink prepared from them within 48 hours prior to admission.
- •Have special requirements for diet.
- •History or presence of any disease or condition which might compromise the Neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal systems or any other body system.
- •During the screening period, vital signs, physical examination, laboratory tests,12-lead electrocardiogram or chest radiograph is abnormal with clinically significant.
- •During the screening period, virological testing, hepatitis B surface antigen or e antigen, hepatitis C antibody, syphilis spirochete antibody, or human immunodeficiency virus (HIV) antibody is positive.
- •Women who tested positive for pregnancy at screening or baseline or lactating
- •Participated in other drug clinical trials and took medication within 3 months prior to screening
研究组 & 干预措施
cohort 1: Albuvirtide
Single dose of 320 mg by intervenous drop infusion for 45 min
干预措施: Albuvirtide (Drug)
cohort 2: Albuvirtide
Single dose of 320 mg by intervenous injection for 0.5 min
干预措施: Albuvirtide (Drug)
cohort 3: Albuvirtide
Single dose of 320 mg by intervenous injection for 3 min
干预措施: Albuvirtide (Drug)
结局指标
主要结局
Peak concentration
时间窗: Day 0-Day 57
Maximum observed plasma concentration (Cmax)
half-time
时间窗: Day 0-Day 57
Time for blood concentration to drop by half-time（t1/2）
Peak time
时间窗: Day 0-Day 57
Time to Cmax ( Tmax)
Area under curve
时间窗: Day 0-Day 57
The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt)
次要结局
- Incidence of Treatment-Emergent Adverse Events(Day 0-Day 63)