NCT04037657已完成1 期
A Phase 1b, Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Dose of HSK3486 in Healthy Female Subjects.
Sichuan Haisco Pharmaceutical Group Co., Ltd0 个研究点目标入组 25 人开始时间: 2015年4月22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
- 25
- 主要终点
- Modified observer's assessment of alertness/sedation（MOAA/S）
研究概览
简要总结
This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18 - 49 years (inclusive)
- •Women of child-bearing potential agreed to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
- •Negative serum pregnancy test
- •In general good health without CS medical history
- •American Society of Anesthesiologists (ASA) Physical Status Classification of I or II
- •Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive)
- •Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBs-Ag), hepatitis C virus antibody (HCV-Ab) and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1
- •Normal or non-CS findings on a physical examination, 12-lead Electrocardiogram (ECG) and vital signs (respiratory rate between 12 and 20 breaths per minute, blood pressure (BP) between 100-140/60-90 mmHg, heart rate between 50-99 beats per minute, temperature between 35.8°C and 37.5°C and pulse oximetry values > 95% on room air)
- •Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the PI decided that out-of-range values were not CS
- •Able to provide written informed consent
- •Willing and able to follow study instructions and likely to complete all study requirements
- •Suitable venous and arterial access
排除标准
- •History of allergy or sensitivity to: propofol, components of Fresofol 1% MCT/LCT propofol, or HSK3486 (excipients soy bean oil, glycerine, triglycerides, purified egg phospholipids, sodium oleate and sodium hydroxide), or plain lignocaine
- •History of CS problems with general anesthesia
- •Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within 2 months prior to screening
- •History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last 3 months CONFIDENTIAL HSK3486 SAD_02 Sichuan Haisco Pharmaceutical Co., Ltd Version: 13 Nov 2015 Page 19 of 513
- •Use of prescription or over the counter medications within 7 days of Investigational Product administration, with the exception of contraceptive medications, paracetamol, oral non-steroidal anti-inflammatory agents, topical over the counter preparations and routine vitamins (if they do not exceed an intake of 20 to 600 times the recommended daily dose), unless agreed as non-clinically relevant by the PI and Sponsor.
- •Standard donation of blood within 30 days of the study
- •Donation of plasma or participation in a plasmapheresis program within 7 days preceding this study
- •Receipt of any investigational study drug within 30 days prior to screening
- •Unable to fast for the 6 hours prior to Investigational Product administration
- •CS (as judged by the Investigator) presence of acute illness (e.g. gastrointestinal illness, infection such as influenza, upper respiratory tract infection) at admission to the clinical study unit
- •Anticipated need for surgery or hospitalization during the study
- •Anatomical abnormality that would potentially interfere with airway management under unconscious sedation or anesthesia
- •History of posture-related gastric reflux more than twice weekly
- •History of seizures or epilepsy
- •History of ischaemic heart disease
- •History of brady- or tachy-dysrhythmias requiring medical care
- •History of asthma, with bronchospasm requiring treatment in the last 3 months
- •Any condition, which in the Investigator's opinion, puts the subject at significant risk, could confound the study results or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
HSK3486
Experimental
0.288 mg/kg ，0.432 mg/kg ，0.540 mg/kg ，0.648 mg/kg，0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
2.5 mg propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Modified observer's assessment of alertness/sedation（MOAA/S）
时间窗: Time Frame: From first dose of study drug until fully alert on day 1
Observe the change of modified observer's assessment of alert /sedation during the whole trial
Safety by measurement of Adverse Events
时间窗: First dose of study drug on day 1
Bispectral index （BIS）
时间窗: From first dose of study drug until fully alert on day 1
次要结局
- Median effective dose (ED50)(From first dose of study drug until fully alert on day 1)
- Peak concentration (Cmax)(From the start of administration to 48 hours after administration)
- Area Under the Curve (AUC0-30min, AUC0-1h, AUC0-last, and AUC0-inf)(From the start of administration to 48 hours after administration)
- Total clearance (CL)(From the start of administration to 48 hours after administration)
- Time to plasma peak concentration(Tmax)(From the start of administration to 48 hours after administration)
研究者
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