CTRI/2018/07/014927Other1 期
A prospective, randomized, double blind, placebo controlled study of intravenously infused ZYKR1 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- Other
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 or female between 18 and 55 years of age.
- •2.Male subjects must agree to use one of the contraception methods during the study.
- •3.Body weight > 50 kg and BMI within the range 18.5-30 kg/m2 (Both inclusive).
- •4.Capable of giving written informed consent, which includes compliance with protocol.
- •5.QTc < 450 msec by Bazettes formula.
- •6.For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited.
排除标准
- •1.History or presence of significant 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-
- •a)cardiovascular, b)cerebrovascular,c)dermatological, d)gastrointestinal, e)gynecological f)hematological, g)hepatic, h)malignancy, i)metabolic, j)musculoskeletal, k)neurological, l)psychiatric, m)renal, n)respiratory,
- •o)venereal, p)any other major disorders
- •3.History or presence of smoking or consumption of tobacco/nicotine products and having a positive urine cotinine test before check-in.
- •4.Difficulty with donating blood.
- •5.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.
- •6.Pulse rate less than 60/minute and more than 100/minute.
- •7.Any clinically significant laboratory or ECG findings during screening.
- •8.Surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening.
- •9.Volunteers who have participated in any drug research study within past 3 months.
- •10.Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
- •11.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.
- •12.History of allergic reaction to any opioid receptor agonist in the past.
- •13.Male subjects not willing to use contraceptives for a period of one month after receiving study drug.
- •14.For gender effect study, female volunteers with following criteria will not be recruited:
- •History of pregnancy or lactation in the past 3 months.
- •Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures.
- •History of less than 1 year of menopause and not using adequate long-term anti-fertility measures.
- •Using hormonal contraceptives.
- •Using hormone replacement therapy.
- •Unable to give assurance for protection against pregnancy for 1 month after the participation in this trial.
- •Positive serum β-hcg level at the screening or check-in visit.
- •15.Subjects with SpO2 <95% (by pulse oximeter)
研究者
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