A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.
详细描述
The study comprises 2 parts: Part A is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Japanese subjects. Part B is a randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Caucasian 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
- Triple (Participant, Care Provider, 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
- •Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:
- •Signed informed consent form (ICF) and able to comply with study requirements
- •Healthy Japanese or Caucasian men and/or women of no childbearing potential aged ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent), and to be specific:
- •For Part A only: Eligible Japanese subjects should have both biological parents and 4 biological grandparents of Japanese descent, and their 4 biological grandparents must be born in Japan.
- •For Part B only: Eligible Caucasian subjects should 1) have both biological parents and 4 biological grandparents of Caucasian descent, and 2) be matched by body weight (± 20% body weight [kg]), height (± 15% height [centimeter (cm)]) and sex to each Japanese subject receiving the highest dose level planned in Part A.
- •Subjects are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Medical Conditions
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data
- •Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
- •Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Positive HBV, HCV and HIV test
- •History or risk for tuberculosis (TB)
研究组 & 干预措施
Part A: Japanese cohort
Three ascending dose levels of either BGB-23339 or placebo.
干预措施: Placebo (Drug)
Part A: Japanese cohort
Three ascending dose levels of either BGB-23339 or placebo.
干预措施: BGB-23339 (Drug)
Part B: Caucasian cohort
One dose level of either BGB-23339 or placebo based on data collected in Part A.
干预措施: BGB-23339 (Drug)
Part B: Caucasian cohort
One dose level of either BGB-23339 or placebo based on data collected in Part A.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: Duration of Study (Up to 11 weeks)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, and electrocardiogram results.
次要结局
- Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to last quantifiable time (AUClast) quantifiable time (AUClast)(Up to Day 10)
- Area under the plasma concentration-time curve (AUC) of BGB-23339 from time zero to end of dosing interval (AUCtau)(Up to Day 10)
- Maximum observed plasma concentration (Cmax) of BGB-23339(Up to Day 10)
- Time to maximum plasma concentration (Tmax) of BGB-23339(Up to Day 10)
- Trough plasma concentration (Ctrough) of BGB-23339(Up to Day 10)
- Apparent terminal elimination half-life (t½) of BGB-23339(Up to Day 10)
- Apparent systemic clearance (CL/F) of BGB-23339(Up to Day 10)
- Metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808(Up to Day 10)
- Apparent volume of distribution (Vz/F) of BGB-23339(Up to Day 10)