NCT04255979已完成1 期
A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers
Shaperon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月5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
- 40
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers
详细描述
HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged from 19 to 45 at screening test
- •BMI 18 kg/m2 ~ 27 kg/m2 at screening test
- •Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests
- •Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion
排除标准
- •Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
- •Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher
- •Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases
- •Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug
- •Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening
- •Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit [Systolic blood pressure (SBP): < 90 mmHg or > 150 mmHg, Diastolic blood pressure (DBP): < 50 mmHg or > 90 mmHg]
- •Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug
- •Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month
- •Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening
- •Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date
- •Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week
- •Caffeine overdose, alcohol overdose or oversmoker
- •Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial
- •Other investigator judged to be unsuitable as clinical subject
研究组 & 干预措施
Cohort 1
Experimental
Single dose of HY209 0.1 mg/kg or placebo.
干预措施: HY209 (Drug)
Cohort 2
Experimental
Single dose of HY209 0.2 mg/kg or placebo.
干预措施: HY209 (Drug)
Cohort 3
Experimental
Single dose of HY209 0.4 mg/kg or placebo.
干预措施: HY209 (Drug)
Cohort 4
Experimental
Single dose of HY209 0.8 mg/kg or placebo.
干预措施: HY209 (Drug)
Cohort 5
Experimental
Single dose of HY209 1.6 mg/kg or placebo.
干预措施: HY209 (Drug)
Cohort 6
Experimental
Single dose of HY209 3.2 mg/kg or placebo.
干预措施: HY209 (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: Up to Day 6
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
次要结局
- Maximum concentration (Cmax) of HY209(Up to Day 2)
- Time of maximum concentration (Tmax) of HY209(Up to Day 2)
- Terminal halif-life (t1/2) of HY209(Up to Day 2)
- Ratio of area under curve infinity (AUCinf) of HY209(Up to Day 2)
- Ratio of area under curve last (AUClast) of HY209(Up to Day 2)
研究者
研究点 (1)
Loading locations...
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