NCT05093270已完成1 期
A First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects
BeiGene3 个研究点 分布在 2 个国家目标入组 92 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Signed informed consent form (ICF) and able to comply with study requirements
- •Healthy men and/or women of no childbearing potential of age ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent) for Parts A, B and D; of age≥ 18 years and ≤ 45 years on the day of signing the ICF (or the legal age of consent) and of Chinese descent for Part C
- •Participants 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
- •Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
- •A nonsterile man with a female partner of childbearing potential must be willing to use a highly effective method of birth control from the time of study enrollment until 90 days after the last dose of study drug
- •A woman of no childbearing potential must meet at least one of the following criteria:
- •Postmenopausal status, defined as: cessation of regular menses for ≥ 12 consecutive months (menopause confirmed by Follicular Stimulating Hormone [FSH] levels and Luteinizing Hormone [LH] levels as defined by the established reference ranges)
- •Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).
排除标准
- •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
- •Abnormal blood pressure as determined by the investigator
- •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
- •Past or intended use of prescription medication ≤ 14 days and over-the-counter (OTC) medication including herbal, vitamins and dietary supplements ≤ 7 days before randomization
- •Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization
- •Has received an investigational product within the following time before randomization: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer)
- •Participation in a prior study that would result in loss of blood or blood products in excess of 500 mL within 56 days before randomization
- •Exposure to ≥ 4 new chemical entities within 12 months before randomization
- •Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization
- •Regular alcohol consumption ≤ 3 months before randomization
- •Regular use of recreational drugs
- •Current use and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 14 days before randomization
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A Dose Escalation (Single Ascending Dose)
Experimental
Up to 5 dose levels of BGB-23339 or Placebo
干预措施: BGB-23339 (Drug)
Part A Dose Escalation (Single Ascending Dose)
Experimental
Up to 5 dose levels of BGB-23339 or Placebo
干预措施: Placebo (Drug)
Part B Dose Escalation (Multiple Ascending Dose)
Experimental
Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A
干预措施: BGB-23339 (Drug)
Part B Dose Escalation (Multiple Ascending Dose)
Experimental
Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A
干预措施: Placebo (Drug)
Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)
Experimental
Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
干预措施: BGB-23339 (Drug)
Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)
Experimental
Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
干预措施: Placebo (Drug)
Part D (Food-Effect Study)
Experimental
Three single dose levels of BGB-23339 under different feeding conditions
干预措施: BGB-23339 (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 7 weeks
Number of participants with clinically significant changes from baseline in vital signs
时间窗: Up to approximately 4 weeks
Vital signs include blood pressure and pulse rate
Number of participants with clinically significant changes from baseline in clinical laboratory values
时间窗: Up to approximately 4 weeks
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
次要结局
- Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D(Up to approximately 4 weeks)
- Apparent terminal elimination half-life (t½) for Parts A, B, C and D(Up to approximately 4 weeks)
- Time to maximum plasma concentration (Tmax) for Parts A, B, C and D(Up to approximately 4 weeks)
- Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D(Up to approximately 4 weeks)
- Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D(Up to approximately 4 weeks)
- Maximum observed plasma concentration (Cmax) for Parts A, B, C and D(Up to approximately 4 weeks)
- Trough plasma concentration (Ctrough) for Parts A, B, and C(Up to approximately 4 weeks)
- Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only(Up to approximately 4 weeks)
- Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D(Up to approximately 4 weeks)
- Apparent systemic clearance (CL/F) for Parts A, B, and C(Up to approximately 4 weeks)
- Apparent volume of distribution (Vz/F) for Parts A, B, and C(Up to approximately 4 weeks)
研究者
研究点 (3)
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