CTRI/2020/08/027011已完成1 期
A prospective, randomized, double blind, single dose, placebo-controlled study to evaluate pharmacokinetics, safety and tolerability of ZYBK2 in healthy adult human volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male and female subjects between 18 and 55 years of age (Both inclusive).
- •2.Body mass index of 18.5 to 30.0 kg/m2 (Both inclusive) with a body weight of 50 to 100 kg (Both inclusive).
- •3.Normal QTc interval at screening and Check In [QTcF ââ?°Â¤450 ms]
- •4.Capable of giving written informed consent, which includes compliance with the study procedures, restrictions, and requirements listed in the protocol.
- •5.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: hematology, serum biochemistry, urinalysis, and serology
- •6.Male subjects and female subjects of childbearing potential must practice highly effective contraception
排除标准
- •1.History or presence of alcoholism or drug abuse within the past 1 year.
- •2.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion: cardiovascular, cerebrovascular, dermatological, gastrointestinal, gynecological, hematological, hepatic, malignancy, metabolic, musculoskeletal, neurological, psychiatric, renal, respiratory, venereal, any other major disorders
- •3.History of clinically significant hypersensitivity, intolerance, or allergies, as determined by the Investigator.
- •4.History or presence of smoking or consumption of tobacco/nicotine products within the past 1 year.
- •5.Difficulty with donating blood.
- •6.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg.
- •7.Pulse rate less than 55/minute and more than 100/minute.
- •8.Any clinically significant laboratory or ECG findings during screening or check-In.
- •9.Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).
- •10.Subjects who have recent illness (eg, fever) within 7 days of check-in
- •11.Volunteers who have participated in any drug research study within past 3 months.
- •12.Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
- •13.Has used prescription drugs and other substances (eg, dietary or herbal supplements such as St Johnââ?¬•s Wort) known to be either significant enzyme inducers or enzyme inhibitors within 4 weeks of Day 0, or use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days of Day 0.
- •14.Use of any over-the-counter (OTC), any prescription medications or alternative tradition of medicine (herbal medicines, homoeopathy, Siddha, Unani, etc.) within the 15 days or 5 half-lives (whichever is longer), prior to receiving study drug that might have impact on the clinical trial as per the investigator discretion.
- •15.A positive urine drugs of abuse test or positive alcohol breath test at check-in.
- •16.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II.
- •17.Female subjects who are pregnant, currently breastfeeding, or attempting to conceive.
- •18.Any disorder that, in the Investigatorââ?¬•s opinion, may interfere with study compliance, such as significant mental, nervous disorder or other illness. In making this assessment, the Investigator must refer to the study information provided including the Investigatorââ?¬•s Brochure.
- •19.Inability to be venipunctured or tolerate venous puncture.
- •20.Any condition or abnormal baseline findings that in the Investigatorââ?¬•s judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
- •21.Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the subject unsuitable for the study.
研究者
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