A randomized, double-blind, placebo-controlled Phase I clinical study to evaluatethe safety, tolerability and pharmacokinetics of ZYAN1, a novel PHD-2 Inhibitor,following oral administration in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.
研究概览
简要总结
This study will be a randomized, double-blind, placebo-controlled, multi-Centre trial. The objective of this study is to evaluate the safety, tolerability and pharmacokinetics of ZYAN1, a novel PHD2 Inhibitor, following oral administration in healthy volunteers.
According to the dosage schedules, the study has been divided in the following three plans- Plan I (single dose study), Plan II (Multiple dose Study), Plan III - Gender and Food effect study. An approximately 84 subjects shall be enrolled. At least one panel will be conducted in centre 2 (India) on selected dose from selected plan as per the study protocol.
The volunteers, who are found normal and healthy at the time of screening, satisfy inclusion and exclusion criteria and are willing to give the informed consent, will be invited to participate in the study.
Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality. Frequency of AEs with ZYAN1 will be compared with the placebo group. Further dose escalation will be stopped as per stopping criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female between 18 and 65 years of age.
- •Hemoglobin: Males -12.8 – 14.9 g/dL and Females 11.3- 14.9 g/dl.
- •Male subjects must agree to use one of the contraception methods during the study.
- •Body weight > 55 kg and BMI within the range
- •Capable of giving written informed consent, which includes compliance with protocol.
- •QTc < 450msec.
- •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
- •Presence or history of severe gastrointestinal disease in the last 6 months.
- •Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL)}.
- •Active liver disease and/or liver transaminase greater than 1.5 X UNL.
- •History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological,dermatological, neurological, psychiatric disease or any other body system involvement).
- •History or presence of significant alcoholism or drug abuse within the past 1 year.
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day) and having a positive urine cotinine test at screening and check-in.
- •Difficulty with donating blood.
- •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.
- •Pulse rate less than 50/minute and more than 100/minute.
- •Any clinically significant laboratory findings during screening.
- •History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening.
- •Major illness and/or major surgery in last 3 months.
- •Volunteers who have participated in any drug research study other than the present trial within past 3 months.
- •Volunteers who have donated one unit (350 ml) of blood in the past 3 months.
- •Use of any over-the-counter (OTC) or prescription medications within the 30 days or 5 half-lives (whichever is longer), prior to receiving study drug.
- •Use of any herbal medicines (eg, St. John’s wort) and supplements within the 30 days prior to receiving study drug.
- •Strenuous activity (as assessed by the investigator) is prohibited from 2 days prior to admission until discharge from the unit.
- •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 3 months after the participation in this trial.
- •Positive urine pregnancy test on the day of check-in.
- •Positive serum β-hCG level at the screening visit.
结局指标
主要结局
Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.
时间窗: Clinical examination, vital signs like oral temperature, sitting blood pressure and pulse and laboratory tests will be done at screening and at time points described as per protocol. | Continuous ECG monitoring and 12-lead ECG will be done as per time points desctibed in the protocol.
次要结局
- 1. Pharmacokinetics (PK) after single and multiple oral dose(administrations in healthy male volunteers.)