NCT06964711已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability and Pharmacokinetics of GW117 ODT in Healthy Volunteers
Beijing Greatway Pharmaceutical Technology Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年7月12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
- 92
- 试验地点
- 1
- 主要终点
- Percentage of participants with at least one safety event
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers
详细描述
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.
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
- •Body weight should be at least 50.0kg for males and 45.0kg for females, with body mass index (weight/height 2) in the range of 19-26 kg/m2
- •The results of physical examination were normal or abnormal without clinical significance;
- •The results of vital signs were normal or abnormal without clinical significance
- •The results of laboratory tests (blood routine, urine routine, liver function, renal function, blood glucose, electrolytes, coagulation function) were normal or abnormal without clinical significance
- •negative results of pregnancy examination
- •normal serological test results (five hepatitis B tests, hepatitis C antibodies, syphilis sero-specific antibodies, HIV antibodies)
- •Normal or approximately normal or abnormal results of 12-lead electrocardiogram were not clinically significant
- •Normal or abnormal chest X-ray findings had no clinical significance
- •The normal or abnormal results of abdominal ultrasound had no clinical significance;
- •Alcohol breath test results were negative
- •Urine nicotine test results were negative
- •Urine drug screening (morphine, methamphetamines, ketamine, dimethylenedioxyamphetamine, and tetrahydrocannabinol acid) was negative
排除标准
- •Allergic constitution or a history of drug or food allergy
- •any medical history that may affect the safety of the trial or the in vivo course of the drug
- •any history of surgery or trauma that may affect the safety of the trial or the course of the drug in vivo
- •currently suffering from any unstable or recurrent disease or disease affecting the course of the drug in vivo
- •a history of drug abuse/dependence in the past 2 years
- •any medications used within 14 days before the test
- •smoking within 2 weeks before medication or during the study period;
- •alcohol abuse [drinking more than 14 units of alcohol per week in the 3 months before screening (1 unit of alcohol ≈360mL of 5% beer or 45mL of 40% spirits or 150mL of 12% wine)], or drinking alcohol within 1 week before medication, or unable to abstain from alcohol during the study
- •participated in other drug clinical trials within 90 days before the trial
- •blood loss or donation of 400mL or more within 90 days before the test;
- •a history of fainting or bleeding
- •lactating women
- •plan to donate sperm or egg, plan to have children, or be unwilling or unable to take effective contraceptive measures within 30 days before the trial to 6 months after the end of the trial
- •abnormal neurological or mental status or language disorder
- •patients with abnormal saliva secretion, severe oral ulcer or other oral mucosal diseases;
- •The investigators considered that they were not suitable to participate in the trial due to other circumstances
研究组 & 干预措施
Placebo
Placebo Comparator
Take the tablet sublingually, Once daily SAD: Take once only MAD: Take for 7 consecutive days
干预措施: Placebo (Drug)
GW117 ODT (Orally disintegrating tablet)
Experimental
Take the tablet sublingually, Once daily SAD: Take once only，0.5mg，1mg，2mg，4mg MAD: Take for 7 consecutive days，1mg，2mg
干预措施: GW117 ODT (Drug)
结局指标
主要结局
Percentage of participants with at least one safety event
时间窗: baseline up to Day 9
Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, electrocardiogram (ECG) evaluations, clinical laboratory assessments, and physical examination findings. Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured.
次要结局
- Pharmacokinetics - time to maximum concentration (Tmax)(baseline up to Day 8)
- Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)(baseline up to Day 8)
- Pharmacokinetics - terminal elimination half life (t1/2)(baseline up to Day 8)
- Pharmacokinetics -maximum plasma concentration (Cmax)(baseline up to Day 8)
研究者
研究点 (1)
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