A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 56
- 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. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.
Safety (i.e., adverse events [AEs], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale [C-SSRS], and Mini-Mental State Examination [MMSE]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older 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, 18-75 years of age.
- •Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- •Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
- •Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
排除标准
- •Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical, surgical or psychiatric condition or disease.
- •History of any illness that, in the opinion of the PI, 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 orthostatic hypotension in the 12 months prior to screening.
- •Clinically significant hypertension at screening.
- •History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.
研究组 & 干预措施
XC130-A10H
XC130-A10H (single dose)
干预措施: XC130-A10H (Drug)
Placebo
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.
Changes from baseline in systolic and diastolic blood pressure
时间窗: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours
Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.
次要结局
- Maximum plasma concentration [Cmax] of XC13-A10H(48 hours)
- Area under the curve [AUC] of XC130-A10H(48 hours)
- Time to reach the maximum plasma concentration [Tmax] of XC130-A10H(48 hours)