A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and multiple doses of APX001 as measured by adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG).
研究概览
简要总结
First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a total of approximately 48 healthy subjects. The MAD portion of the study will enroll four cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy subjects.
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
- Double (Participant, Investigator)
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
- •Women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug.
- •Males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug.
- •Screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health.
- •No significantly abnormal findings on physical examination, ECG and vital signs.
- •Willing and able to provide written informed consent.
排除标准
- •Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
- •History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
- •Use of prescription medication within 14 days prior to the first dose of study drug and throughout the study.
- •Use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study.
- •Positive results on any of the following Screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
研究组 & 干预措施
Cohort 9
multiple intravenous doses
干预措施: APX001 multiple dose 3 (Drug)
Cohort 9
multiple intravenous doses
干预措施: Matching Placebo (Drug)
Cohort 10
multiple intravenous doses
干预措施: APX001 multiple dose 4 (Drug)
Cohort 10
multiple intravenous doses
干预措施: Matching Placebo (Drug)
Cohort 1
single intravenous dose
干预措施: APX001 single dose 1 (Drug)
Cohort 1
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 8
multiple intravenous doses
干预措施: Matching Placebo (Drug)
Cohort 2
single intravenous dose
干预措施: APX001 single dose 2 (Drug)
Cohort 2
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 3
single intravenous dose
干预措施: APX001 single dose 3 (Drug)
Cohort 3
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 4
single intravenous dose
干预措施: APX001 single dose 4 (Drug)
Cohort 4
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 5
single intravenous dose
干预措施: APX001 single dose 5 (Drug)
Cohort 5
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 6
single intravenous dose
干预措施: APX001 single dose 6 (Drug)
Cohort 6
single intravenous dose
干预措施: Matching Placebo (Drug)
Cohort 7
multiple intravenous doses
干预措施: APX001 multiple dose 1 (Drug)
Cohort 7
multiple intravenous doses
干预措施: Matching Placebo (Drug)
Cohort 8
multiple intravenous doses
干预措施: APX001 multiple dose 2 (Drug)
结局指标
主要结局
Safety and tolerability of single and multiple doses of APX001 as measured by adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG).
时间窗: 21 days
次要结局
- Pharmacokinetics of single and multiple doses of APX001 as measured by terminal phase half-life (t1/2).(21 days)
- Pharmacokinetics of single and multiple dose of APX001 as measured by accumulation ratio.(21 days)
- Pharmacokinetics of single and multiple doses of APX001 as measured by area under the curve (AUC).(21 days)
- Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).(21 days)
- Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).(21 days)
- Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).(21 days)