A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
研究概览
简要总结
This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design.
详细描述
Four cohorts (dose level A, B, C, and D) of up to 6 evaluable volunteers per cohort are planned to be sequentially accrued to receive Careseng 1370 1, 2, and 3 sachets per day, 4,000 mg/sachet before meal (starting from 1 sachet). At least 5 days of staggering and with the investigator's judgement of no safety concern will be required to administer the next volunteer for the first three volunteers of each cohort. The staggering time is counted from Day 1 of one volunteer to Day 1 of the next volunteer.
Careseng 1370 should be taken around 1 hour before meal. No volunteer is allowed to be assigned to more than 1 dose level. All dose escalation/de-escalation decisions will be made by the Data and Safety Monitoring Board (DSMB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult aged between 20-40 years old (inclusive)
- •Physically and mentally healthy volunteer as confirmed by an interview, medical history, clinical examination, chest X-rays, and electrocardiogram. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion.
- •Body Mass Index (BMI) between 18.5 and 24, inclusive (BMI will be calculated as weight in kilogram [kg]/(height in meters)2 [m2])
- •Clinically normal hematology, biochemistry and urinalysis determinations based on investigator's discretion. Volunteer with non-clinically significant signs or symptoms may be eligible at investigator's discretion.
- •Volunteer is willing and able to comply with study procedures and sign informed consent prior to initiation of any study-mandated procedures.
排除标准
- •Volunteer who has a history or evidence of a medical condition that would expose them to a risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
- •Volunteer has received any other investigational agent within 28 days prior to the first dose of study drug
- •Volunteer has taken or potentially takes any herbal medication/supplements/medicinal food, prescription medication and/or over-the-counter medication within 2 weeks prior to the first dose of study drug
- •Volunteer has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the first dose of study drug
- •Female volunteer of childbearing potential who:
- •is lactating; or
- •has positive pregnancy test result at eligibility checking; or
- •refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit to Final visit.
- •Acceptable forms include:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
- •Male volunteer with female spouse/partners who are of childbearing potential refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening visit until Final visit
- •Known or suspected allergy or hypersensitivity to any ingredients of study product
- •With history of stroke, myocardial infarction, or Coronary Artery Bypass Graft (CABG) surgery within the last 6 months prior to the screening visit
- •With history of cardiac failure (NYHA class 2 or above), unstable angina, or life-threatening arrhythmia within the last 6 months prior to the screening visit Note: NYHA = New York Heart Association
- •With blood pressures as systolic blood pressure < 90 mmHg or > 170 mmHg or diastolic blood pressure < 50 mmHg or > 120 mmHg at eligibility checking
- •History of psychiatric disorder
- •History of left ventricular outflow obstruction, such as aortic stenosis and hypertrophic cardiomyopathy
- •With a history of human immunodeficiency virus (HIV) infection or hepatitis B or C infection
- •Plan to receive surgery from Screening visit until Final visit
- •Known or suspected hypersensitivity to any component of Careseng 1370, including components in plants of genus Panax, Tween 80, Kolliphor® P188, Fujicalin, and ginseng flavor
研究组 & 干预措施
Careseng 1370 Level A
Level A (1 sachet): 1 sachet before breakfast. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)
干预措施: Careseng 1370 (Drug)
Careseng 1370 Level B
Level B (2 sachets): 1 sachet before breakfast, 1 sachet before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)
干预措施: Careseng 1370 (Drug)
Careseng 1370 Level C
Level C (3 sachets): 1 sachet before breakfast, 2 sachets before lunch. Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)
干预措施: Careseng 1370 (Drug)
Careseng 1370 Level D
Level D (1 sachet)(modified cohort): 1 sachet before breakfast on 1st, 3rd and 5th days.
Careseng 1370 granule 4,000 mg sachet consisted of 652 mg (16.3%, w/w) DS-1370 drug substance powder (dry extracts of Panax notoginseng stems and leaves)
干预措施: Careseng 1370 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
时间窗: Day -14 to Day 22
An AE is any untoward medical occurrence in a volunteer or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. Laboratory abnormalities should not be recorded as AE unless determined to be clinically significant by Investigator. A SAE is defined as an AE meeting one of the following conditions: * Death during the period of protocol defined surveillance * Life Threatening Event (defined as a participant at immediate risk of death at the time of the event) * An event requiring in volunteer hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance * Results in congenital anomaly or birth defect * Results in a persistent or significant disability/incapacity * Based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Number of Participants With no Change From Baseline to Applicable Post-dosing Visits in Body Weight (kg)(Day -14 to Day 22)
- Number of Participants With Clinical Laboratory Abnormalities(Day -14 to Day 22)
- Number of Participants With Vital Signs Abnormalities(Day -14 to Day 22)
- Number of Participants With Physical Examination Abnormalities(Day -14 to Day 22)
- Plasma Concentration of Marker Ingredients in Careseng 1370, 20(S)-Protopanaxadiol (PPD) and Its Metabolites(Day 2 to Day 8)
- Participants With Abnormal Sinus Rhythm(Day -14 to Day 22)
- Significantly Abnormal Ventricular Rate Compared to Baseline(Day -14 to Day 22)
- Significantly Abnormal PR, QRS, QT, QTc Intervals Compared to Baseline(Day -14 to Day 22)