NCT03430999已完成1 期
SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Egetis Therapeutics1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年11月7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
- 48
- 试验地点
- 1
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, 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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
- •Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- •Non-smoker or not smoking for at least 12 months
- •Be first generation Japanese (For Group 1 only), defined as:
- •Born in Japan
- •Has 2 Japanese biological parents and 4 Japanese biological grandparents
- •Has lived outside of Japan for less than 5 years
- •Has made no significant changes in lifestyle, including diet, since leaving Japan
排除标准
- •Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
- •Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- •Has a history of drug or alcohol abuse
- •Has previously received calmangafodipir or mangafodipir
- •Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
研究组 & 干预措施
Group 2 (Caucasian) Calmangafodipir
Experimental
干预措施: Calmangafodipir (Drug)
Group 1 (Japanese) Calmangafodipir
Experimental
干预措施: Calmangafodipir (Drug)
Group 1 (Japanese) Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Group 2 (Caucasian) Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: From signing of informed consent through the last follow up visit (up to Day 10)
Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.
次要结局
- Ae%(4 hours and 24 hours post-dose)
- Cmax(predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose)
- Ae(4 hours post-dose and 24 hours post-dose)
- tmax(predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose)
- AUC(0-last)(predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose)
研究者
研究点 (1)
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