ACTRN12618001769279招募中1 期
A Phase I, randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability and pharmacokinetics of single and repeat doses and food effect of AK-119 administered orally to healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy volunteer subjects eligible for inclusion in this study have to fulfil all of the following inclusion criteria:
- •1.Male and female subjects 18-55 years of age, inclusive, at the time of screening
- •2.Able to provide written informed consent prior to the performance of any study specific procedures
- •3.Subjects with a BMI between 18.0 and 30.0 kg/m2, inclusive
- •4.A 12-lead ECG at screening or pre-dose assessment that, in the opinion of the investigator, has no abnormalities that compromise subject’s safety in this study.
- •5.Female subjects of non-childbearing potential, defined as (1) having a documented tubal ligation at least 6 weeks prior to dosing; (2) having had a surgical bilateral oophorectomy (with or without hysterectomy); (3) at least 12 months of spontaneous amenorrhoea with follicle stimulating hormone (FSH) > 40 MIU/ml.
- •6.Female subjects of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in (Day -1), AND;
- •Agrees to abstinence for the duration of the study and until 4 weeks after dosing with study drug;
- •OR agrees to use condoms plus a highly-effective form of contraception (associated with a less than 1% failure rate when applied consistently and correctly); i.e. intra-uterine device or hormonal contraception associated with suppression of ovulation, from screening until 4 weeks after dosing with study drug;
- •OR has only same-sex partners when this is her preferred and usual lifestyle.
- •7.Male subjects with female partners of child-bearing potential must agree abstinence or to use condoms plus partner use of a highly-effective form of contraception (intrauterine device, hormonal contraception) for the duration of the study and until 12 weeks after dosing with study drug. They must also agree to not donate semen during the same time frame.
- •8.Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results
- •9.Subjects who are willing and able to comply with all study assessments and adhere to the protocol schedule.
- •10.The participant will be normotensive at screening with systolic blood pressure (BP) between 95 and 140mmHg, diastolic BP between 50 and 95mmHg, and heart rate (HR) between 55 and 90 beats per minutes (bpm).
排除标准
- •Healthy volunteer subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
- •11.Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
- •12.Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- •13.Clinically significant history or presence of any gastrointestinal pathology (e.g., chronic diarrhoea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g., diarrhoea, vomiting), liver or kidney disease, Gilbert’s syndrome, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •14.Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, haematological, malignant, immunologic, psychiatric, metabolic or other uncontrolled systemic disease
- •15.Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- •16.Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrolment, a history of suicide plan
- •17.Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, positive urine screen for drugs of abuse.
- •18.Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- •19.Have clinical signs of active infection and/or a temperature of equal or greater than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator
- •20.Have evidence of drug abuse or positive urine drug screen at screening
- •21.Subjects who have smoked more than 10 cigarettes a day in the last 12 months
- •22.Have evidence of alcohol abuse within 6 months prior to screening visit (i.e., more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol])
- •23.Be unable to provide a pre-dose blood sample without undue trauma or distress
- •24.Anticipate surgery within the trial period or history of major surgery within 3 months of screening
- •25.History of hypersensitivity to any other S1P receptor modulator
- •26.Use of prescription medication (including anticoagulants) within 14 days prior to administration of study treatment or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study treatment, except for topical products without systemic absorption unless otherwise agreed by sponsor.
- •27.A depot injection or an implant of any drug within 3 months prior to administration of study treatment, with the exception of a contraceptive implant
- •28.Subjects with a history or presence (at screening or first baseline) of any clinically significant ECG abnormalities including, but not limited to any type of AV blocks or any of the following ECG abnormalities at screening or baseline:
- •oPR > 220 ms
- •oQRS complex > 120 msec
- •oQTcF >470 msec (females) or > 45
研究者
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