A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs)
研究概览
简要总结
The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion 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
- 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/or female participants aged 18 to 55 years, inclusive.
- •A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
- •Females must be of nonchildbearing potential.
排除标准
- •Estimated glomerular filtration rate <90 mL/min/1.73 m2
- •Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
- •Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
- •History of alcohol abuse or excessive intake of alcohol
研究组 & 干预措施
Cohort 1
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
干预措施: CS-1103 (Drug)
Cohort 2
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
干预措施: CS-1103 (Drug)
Cohort 3
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
干预措施: CS-1103 (Drug)
Cohort 4
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
干预措施: CS-1103 (Drug)
Placebo
2 participants for each cohort were administered with placebo.
Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
干预措施: Sterile Saline (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs)
时间窗: 3 days plus 8 days for follow-up
Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).
Number of Participants by Severity of AEs
时间窗: 3 days plus 8 days for follow-up
Severity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.
次要结局
- Plasma PK Parameter: Vz(End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr)
- Urine PK Parameter: Fe (0-last)(Time intervals from 0-24 hours after IV administration of CS-1103)
- Plasma PK Parameter: CL(End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr)
- Plasma Pharmacokinetic (PK) Parameter: Cmax(End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr)
- Plasma PK Parameter: Tmax(End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr)
- Plasma PK Parameter: t1/2(End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr)