NCT05492630已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Randomized, Open-label, Food Effect Study of HEC73077 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- •Be able to complete the study according to the trail protocol.
- •Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- •subjects and must be 18 to 45 years of age inclusive.
- •Body weight ≥ 45 kg(for female) or ≥ 50 kg(for male) and body mass index（BMI）between 18 and 28 kg / m^2, inclusive, at screening.
- •There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening.
- •Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
排除标准
- •Use of >5 cigarettes per day during the past 3 months.
- •Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- •History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 14 units/week).
- •Positive results from urine drug screen test.
- •Donation or loss of blood over 450 mL within 3 months prior to screening.
- •Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening.
- •Use of any prescription or non-prescription medications within 14 days prior to initial dosing
- •Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- •Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- •Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
HEC73077 tablets
Experimental
Single-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.
干预措施: HEC73077 tablets (Drug)
HEC73077 placebo tablets
Placebo Comparator
Single-Dose Study: There will be a total of 7 dose cohorts. Multiple-dose Study: There will be a total of 4 dose cohorts.
干预措施: HEC73077 placebo tablets (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 19 days
Incidence of adverse events
Cmax
时间窗: Day 1-17
Maximum plasma concentration of study drugs
AUC0-∞
时间窗: Day 1-17
area under the concentration versus time curve (AUC) from time zero to infinity
次要结局
未报告次要终点
研究者
研究点 (1)
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