hzVSF-v13 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics After Intravenous and Subcutaneous Administration in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes from baseline QTc interval at each time point
研究概览
简要总结
Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo in healthy subjects.
详细描述
A phase I, double-blind, placebo-controlled, single and multiple dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females (of either childbearing or non-childbearing potential), of any race, between 18 and 60 years of age, inclusive on day of screening.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive on day of screening.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
研究组 & 干预措施
Group A1 (hzVSF-v13 50mg, intravenous, single dose)
Single administration (intravenous) of 50mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A2 (hzVSF-v13 100mg, intravenous, single dose)
Single administration (intravenous) of 100mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A3 (hzVSF-v13 200mg, intravenous, single dose)
Single administration (intravenous) of 200mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A4 (hzVSF-v13 400mg, intravenous, single dose)
Single administration (intravenous) of 400mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A5 (hzVSF-v13 800mg, intravenous, single dose)
Single administration (intravenous) of 800mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A6 (hzVSF-v13 1200mg, intravenous, single dose)
Single administration (intravenous) of 1200mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (intravenous, single dose) (Drug)
Group A7 (hzVSF-v13 100mg, subcutaneous, single dose)
Single administration (subcutaneous) of 100mg hzVSF-v13 on Day 1.
干预措施: hzVSF-v13 (subcutaneous, single dose) (Drug)
Group B1 (hzVSF-v13 100mg, intravenous, multiple dose)
Multiple administration (intravenous) of 100mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.
干预措施: hzVSF-v13 (intravenous, multiple dose) (Drug)
Group B2 (hzVSF-v13 400mg, intravenous, multiple dose)
Multiple administration (intravenous) of 400mg hzVSF-v13 on Day 1, Day 15, Day 29, Day 43, Day 57.
干预措施: hzVSF-v13 (intravenous, multiple dose) (Drug)
Placebo (subcutaneous, single dose)
Single administration (subcutaneous) of placebo on Day 1.
干预措施: Placebo (subcutaneous, single dose) (Drug)
Placebo (intravenous, single dose)
Single administration (intravenous) of placebo on Day 1.
干预措施: Placebo (intravenous, single dose) (Drug)
Placebo (intravenous, multiple dose)
Multiple administration (intravenous) of placebo on Day 1, Day 15, Day 29, Day 43, Day 57.
干预措施: Placebo (intravenous, multiple dose) (Drug)
结局指标
主要结局
Changes from baseline QTc interval at each time point
时间窗: Group A1~A7: Day 1 (pre-dose), Day 8, Day 15, Day 22, Day 29, Day 36, Day 50, Day 64, Day 78, Day 92 Group B1~B2: Day 1 (pre-dose), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 98, Day 162
Safety assessments of hzVSF-v13 by ECG parameter (QTc interval), ECG Bandwidth: 100\~300Hz
次要结局
- Pharmacokinetic - AUC0-∞(Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98)
- Pharmacokinetic - Cmax(Group A1~A7: Predose, 0.25 ~ 2184 hours postdose Group B1~B2: Day 1 (predose ~ 48 hours postdose), Day8, Day15, Day29, Day43, Day 57 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 hours postdose), Day71, Day85, Day98)