NCT03715114Unknown1 期
A Double-blind, Randomized, Placebo Controlled Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Sodium Oligo-mannurarate (GV-971) Capsule in Healthy Chinese Subjects
Shanghai Greenvalley Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax)
研究概览
简要总结
To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects;
- •Age：≥18 and ≤40 on the date signing informed consent;
- •Body mass index (BMI): 19-26 kg/m2 and the weight ≥50 kg for male and ≥45 kg for female；
- •Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.
排除标准
- •Subjects may be allergic to GV-971 in the opinion of the investigator;
- •With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to cardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
- •Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 12 weeks prior to screening;
- •Participation in any investigational drug or medical instrument study within 3 months prior to screening;
- •Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening;
- •Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening;
- •Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
- •Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
- •Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination;
- •Positive seurology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test;
- •Vegetarian or person with dietary restrictions;
- •Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study;
- •Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
研究组 & 干预措施
GV-971 900 mg
Experimental
900 mg oral
干预措施: GV-971 (Drug)
GV-971 1200 mg
Experimental
1200 mg oral
干预措施: GV-971 (Drug)
GV-971 1500 mg
Experimental
1500 mg oral
干预措施: GV-971 (Drug)
Placebo
Placebo Comparator
Oral placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax)
时间窗: 2 day and 7 day
Cmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
Half life time (T1/2)
时间窗: 2 day and 7 day
T1/2 will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
Area under the plasma concentration versus time curve (AUC)
时间窗: 2 day and 7 day
AUC will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
Time to the peak drug concentration (Tmax)
时间窗: 2 day and 7 day
Tmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
次要结局
- Adverse Event (AE)(7 days)
研究者
研究点 (1)
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