ACTRN12619000127101已完成1 期
Randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) following a single-dose oral administration of ZY-19489 in healthy adult volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Male or female (non-pregnant, non-lactacting) aged 18 -55 years inclusive
- •2. Total body weight greater than or equal to 50kg and BMI between 18-32kg/m2 (inclusive)
- •3. Certified as healthy by a comprehensive clinical assessment
- •4. Screening vital signs (measured after 5 minutes in the supine position):
- •- 90 mmHg - greater than or equal to - systolic blood pressure (SBP) - greater than or equal to - 140 mmHg,
- •- 40 mmHg - greater than or equal to - diastolic blood pressure (DBP) - greater than or equal to - 90 mmHg,
- •- 40 bpm - greater than or equal to - heart rate (HR) - greater than or equal to - 100 bpm.
- •5. At screening and before dosing with investigational medicinal product (IMP): QTcF - greater than or equal to - 450 ms, QTcB - greater than or equal to 450 ms (male subjects); QTcF - greater than or equal to - 470 ms, QTcB - greater than or equal to - 470 ms (female subjects); PR interval - greater than or equal to - 210 ms.
- •6. Heterosexual female subjects of childbearing potential should be using an insertable, injectable, transdermal or combination oral contraceptive approved by the TGA combined with a barrier contraceptive
- •7. Completion of the written informed consent process prior to undertaking any study related procedure.
- •8. Must be willing and able to communicate and participate in the whole study
排除标准
- •1. Haematology, clinical chemistry or urinalysis results at screening or on admission prior to IMP administration that are outside of Sponsor-approved clinically acceptable laboratory ranges and are considered clinically significant by the Investigator.
- •2. Participation in any investigational product study within the 12 weeks preceding IMP administration.
- •3. Symptomatic postural hypotension at screening irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure greater than or equal to 20 mmHg within 2-3 minutes when changing from supine to standing position.
- •4. History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals
- •or house dust mite that are untreated and asymptomatic at the time of dosing can be enrolled in the study.
- •5. History of convulsion (including intravenous drug or vaccine-induced episodes).A medical history of a single febrile convulsion during childhood is not an exclusion criterion.
- •6. Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder.
- •7. History of malignancy of any organ system (other than localised basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
- •8. Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
- •9. Subjects who have received psychiatric medications within 1 year prior to enrolment, or who have been hospitalised within 5 years prior to enrolment for either a psychiatric illness or due to danger to self or others.
- •10. History of more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
- •The Beck Depression Inventory will be used as an objective tool for the assessment of depression at screening. In addition to the conditions listed above, subjects with a score of 20 or more on the Beck Depression Inventory and/or a response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) will not be eligible for participation. These subjects will be referred to a general practitioner or medical specialist as appropriate.
- •Subjects with a Beck score of 17 to 19 may be enrolled at the discretion of the Investigator if they do not have a history of the psychiatric conditions mentioned in this criterion and their mental state is not considered to pose additional risk to the health of the subject or to the execution of the study and interpretation of the data gathered.
- •11. History of recurrent headache (e.g. tension-type, cluster or mi
研究者
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