A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Multiple Dose Safety Outcome Measures
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
详细描述
The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, 18 to 55 years of age, inclusive.
- •Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.
- •Female subjects of child-bearing potential must have a negative pregnancy test result and agree to use highly effective contraception consisting of two forms of birth control
- •Subjects and their partners of childbearing potential must use two medically approved methods of contraception and the subjects should refrain from sperm/egg donation for the duration of the study and for 3 months after drug administration
排除标准
- •Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.
- •History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- •People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).
- •History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- •Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).
- •Received an investigational drug within 30 days or 5 xT1/2 whichever is longer prior to the first dose of our study for small molecule; or within 90 days or 5 x T1/2 whichever is longer prior to the first dose of our study drug; or device study within 90 days prior to screening or more than 4 times per year.
- •History of drug and/or alcohol abuse or addiction.
- •Use of >5 cigarettes or equivalent nicotine-containing product per day.
研究组 & 干预措施
AP303
AP303
干预措施: AP303 300 μg (Drug)
AP303
AP303
干预措施: AP303 600 μg (Drug)
Placebo
Placebo
干预措施: Placebo 50 μg (Drug)
Placebo
Placebo
干预措施: Placebo 150 μg (Drug)
Placebo
Placebo
干预措施: Placebo 300 μg (Drug)
AP303
AP303
干预措施: AP303 50 μg (Drug)
AP303
AP303
干预措施: AP303 150 μg (Drug)
Placebo
Placebo
干预措施: Placebo 600 μg (Drug)
结局指标
主要结局
Multiple Dose Safety Outcome Measures
时间窗: From baseline to Day 28
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
Cmax after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Tmax after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
AUC0-last after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Single Dose and Food Effect Safety Outcome Measures
时间窗: From baseline to Day 14 (Day 29 for Food Effect)
Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
Ae and CLR (if warranted) after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
t1/2 after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Ctrough after multiple dose
时间窗: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
PK characteristics after multiple dose
V/F after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
t1/2 after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
V/F after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Tmax after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
AUC0-inf after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Cmax after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
AUC0-τ after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Cav after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Ae and CLR (if warranted) after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
CL/F after single dose
时间窗: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Rac after multiple dose
时间窗: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
次要结局
- Effect of Food on the single dose Tmax(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose AUC0-last(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose AUC0-inf(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose Cmax(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose t1/2(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose CL/F(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose Ae and CLR (if warranted)(Pre-dose to 96 hours post-dose)
- Effect of Food on the single dose V/F(Pre-dose to 96 hours post-dose)