ACTRN12619001607167已完成1 期
A Phase I, randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of OCX063 administered orally to healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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 45 Years（—）
- 性别
- Male
入选标准
- •Participants who;
- •- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- •- Are male aged 18 to 45 years old inclusive at the time of consent.
- •- Are in good general health without clinically significant medical history.
- •- Have a body mass index (BMI) less than 30kg/m2.
- •- Have negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results.
- •- Agree to practice effective contraception during the study period and for 2 months after their last dose of study drug.
排除标准
- •Participants who;
- •- Have received any other study drug within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
- •- 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 study drug.
- •- Have received blood products within 1 month prior to Screening.
- •- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months.
- •- Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years.
- •- 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 blood draws.
- •- 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 Screening, a history of suicide plan
- •- Have any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead electrocardiogram (ECG).
- •- Have any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- •- Have high risk behaviours for HIV or hepatitis B or C (i.e. injecting drug use, commercial sex work, unsafe sexual practices)
- •- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma
- •- Have clinical signs of active infection and/or a temperature of > 38.0°C at the time of Screening. Study entry may be deferred at the discretion of the Principal Investigator
- •- Have a positive alcohol breath test or urine screen for drugs of abuse at Screening or check-in, or evidence of drug or alcohol abuse in the investigator’s opinion.
- •- Are unable to provide a blood sample without undue trauma or distress.
- •- Have any other medical condition or significant co-morbidities, or any finding during Screening, which may interfere with the study objectives in the investigator’s opinion.
- •- Have a history of or current clinically relevant social, clinical, or psychiatric condition which, in the opinion of the investigator, makes the participant unsuitable for participation in the study
研究者
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