A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions. Dose escalation will be supervised by a Safety Monitoring Board (SMB). Dose escalation to the next dose level will not take place until the SMB has determined that adequate safety, tolerability, PK, and core-lab analyzed ECGs from the previous cohort and all previous cohorts have been demonstrated to permit proceeding to the next cohort. PK data from all available cohorts will be used to guide the dose-escalation decisions.
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)
盲法说明
Double-blind
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, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
- •Body mass index (BMI) ≥ 18 and ≤ 30.0 kg/m2 at screening.
- •Medically healthy with no clinically significant finding in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as judged by the PI or designee. Creatinine must be within the upper limit of normal at screening.
- •Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •History of clinically significant hypotension.
- •History of lightheadedness, dizziness or syncope in the 12 months prior to screening.
研究组 & 干预措施
XC101-D13H
single dose
干预措施: XC101-D13H (Drug)
Placebo
single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: pre-dose through 14 days post-dose
Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.
次要结局
- Maximum plasma concentration [Cmax] of XC101-D13H(48 hours)
- Area under the curve [AUC] of XC101-D13H(48 hours)
- Time to reach maximum plasma concentration [Tmax] of XC101-D13H(48 hours)