A Multiple-dose, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.
详细描述
Two groups are initially set up, starting from Group 1 and progressing sequentially to Group 2. After all volunteers in the first group (900 mg BID group) complete the safety follow-up on the 4th day after the last dose (i.e. D10), the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration. The preferred dose for the second group is 900 mg TID, and if there are safety risks found after the Group 1 study, it will be adjusted to 1200 mg BID or other appropriate dosage and frequency.
A total of 24 volunteers are planned to be enrolled, with 12 volunteers in each group. The trial drug and placebo will be allocated in a 3:1 ratio, with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years old, males or females;
- •Body weight no less than 45 kg, Body Mass Index of 18 to 25 kg/m2;
- •Vital signs examination, physical examination, laboratory examination and electrocardiogram examination results were normal or abnormal without clinical significance;
- •Subjects who are willing to take proper contraceptive during the study and within 3 months after the last administration;
- •Subjects who are able to understand and follow the study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.
排除标准
- •Subjects with hypersensitivity to deuremidevir hydrobromide for suspension or any of the excipients;
- •Subjects with allergic diseases or allergic constitution;
- •Subjects with central nervous system, cardiovascular system,gastrointestinal, respiratory system, urinary, Hematologic System,metabolic disorders that require medical intervention or other diseases(such as psychiatric history) that are not suitable for clinical trials;
- •Subjects with acute upper respiratory tract infection within 2 weeks before screening;
- •Subjects who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (except female physiological blood loss);
- •Subjects who have participated in clinical trials of other drugs within 90 days before screening;
- •Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
- •Subjects who have consumed grapefruits, pomelos, oranges, etc. within the previous 7 days before screening and do not agree to stop consuming the above fruits and beverages during the trial period;
- •Being a drug addict or alcohol addict within one year before screening,being an alcoholic at present or in the past (drinking more than 14 standard units per week, and one standard unit contains 14 g of alcohol,such as 360 mL of beer or 45 mL of strong liquor with 40% alcohol content or 150 mL of wine), or being positive in the alcohol breath tests;
- •Subjects who smoked more than 5 cigarettes a day within one year before screening;
- •Subjects who can't quit smoking or drinking during the trial period;
- •Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);
- •Abnormal chest X-ray or CT results with clinical significance;
- •Pulse rate>100 beats per minute, or systolic blood pressure ≥ 140 mmHg or<90 mmHg, or diastolic blood pressure ≥ 90 mmHg or<50 mmHg at screening or baseline;
- •Total bilirubin (TBIL) > upper limit of normal value (ULN), Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 times ULN at screening or baseline;
- •The glomerular filtration rate (eGFR) < 90 ml/min at screening or baseline;
- •Any of the following blood routine examination results during screening or baseline were lower than the lower limit of normal: white blood cell count, absolute value of lymphocytes, percentage of lymphocytes, percentage of neutrophils, absolute value of neutrophils;
- •Abnormal ECG at screening or baseline, including QTcF (after heart rate correction) >450 ms for males and > 470 ms for females in single examinations, and/or other abnormalities with clinical significance;
- •Pregnant or lactating females, or male volunteers whose spouses have planned pregnancy within 3 months;
- •The investigator believes that there are other unsuitable factors for this volunteer to participate this trial.
研究组 & 干预措施
Deuremidevir Hydrobromide for Suspension 900mg group, twice a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q12h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension (Drug)
Deuremidevir Hydrobromide for Suspension 900mg group, twice a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q12h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension Placebo (Drug)
Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q8h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q8h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension (Drug)
Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q8h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q8h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension Placebo (Drug)
Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 1200mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 1200mg, orally, Q12h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension (Drug)
Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day
9 subjects will receive Deuremidevir Hydrobromide for Suspension 1200mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 1200mg, orally, Q12h, 5.5 days.
干预措施: Deuremidevir Hydrobromide for Suspension Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From Day1 to Day10 after administration
Incidence of Treatment-Emergent Adverse Events
次要结局
- Cmax(168 hours after administration)
- Tmax(168 hours after administration)
- AUC0- t(168 hours after administration)
- AUC0-∞(168 hours after administration)
- t1/2(168 hours after administration)