ACTRN12624000023550招募中1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers.
OliX AU Pty Ltd0 个研究点目标入组 70 人开始时间: 2024年1月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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 65 Years（—）
- 性别
- All
入选标准
- •1.Capable of providing written Informed consent.
- •2.Healthy male or female, aged between 18 and 65 years, inclusive at screening.
- •3.Liver fat content less than 6% as determined by MRI-PDFF. Negative cirrhosis screen, human immunodeficiency virus, viral hepatitis B and C serology, autoimmune hepatitis (Liver Kidney Microsomal Liver [LKM] Antibody), transferrin saturation < 45%, at Screening.
- •4.On a stable diet for at least 4 weeks prior to Day -1, with no plans to significantly alter lifestyle for the duration of the study.
- •5.Stable health status, as established by physical examination and medical history.
- •6.Participant is willing to refrain from consuming caffeine and/or xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas), for:
- •7.Participants must have received at least 3 doses of a Therapeutic Goods Association approved COVID-19 vaccine, with the most recent dose administered > 1 week prior to administration of study drug.
- •8.Female participants must be of non-childbearing potential i.e., surgically sterilised or post-menopausal or, if of childbearing potential:
- •a.Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1.
- •b.Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days
- •c.If not exclusively in a same-sex relationship, must agree to use adequate contraception
- •d.If in a same-sex relationship, no form of contraception is required.
- •11.Male participants must:
- •a.Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
- •b.If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception
- •c.If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom.
排除标准
- •1.Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee).
- •2.In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease.
- •3.Use of an investigational agent or device within 30 days or 5 half-lives of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.
- •4.In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.
- •5.Participant smokes greater than 5 cigarettes per week and/or is unwilling to refrain from smoking (and use of any tobacco products or nicotine-containing products) whilst confined to the clinical unit.
- •6.History of substance dependence (within the last 12 months) or positive urine drug screen at screening or excessive alcohol consumption during screening.
- •7.Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication/vitamins/supplements within 7 days prior to the first dose of study drug. Exceptions include contraception, occasional paracetamol (up to a maximum of 2 grams per day). Use of St. John’s Wort (hypericin) may not have been taken within 30 days prior to first dose of study drug.
- •8.Use of any vaccinations within 14 days prior to the first study drug administration (vaccination for Covid-19 is permitted with the most recent dose administered greater than 1 week prior to first study drug administration).
- •9.In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.
- •10.Has contraindications to MRI (e.g., metal implants [excluding Titanium]; severe claustrophobia and inability to lie flat for 1 hour).
- •11.Has international normalized ratio (INR) greater than 1.3.
- •12.Has platelet count less than 140x10^9/L.
- •13.Has transferrin saturation greater than 45%.
- •14.Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- •15.Participants with history or pre-existing renal disease, as defined below:
- •a.estimated glomerular filtration rate less than 60 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) or
- •b.urinary albumin-to-creatinine ratio greater than 10 mg/µmol (100 mg/g).
- •16.Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and/or syncope and/or clinically significant cardiovascular event within the last 6 months prior to the Screening Visit.
- •17.Participants with a positive SARS-CoV-2 infection (polymerase chain reaction [PCR] or rapid antigen test [RAT] as deemed appropriate by the site’s SOPs or PI discretion) at Screening or Day -1 Visit.
- •18.Participants with a significant Coronavirus disease 2019 (COVID-19) illness within 6 months of enrolment, defined by one of the following:
- •c.Participants with a diagnosis of COVID-19 pneumonia based on radiological assessment.
- •d.Participants with diagnosis of COVID-19 with significant findings from pulmonary imaging tests.
- •e.Participants with a diagnosis of COVID-19 requiring hospitalization and/or oxygen supplementation th
研究者
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