ACTRN12615000583549已完成1 期
A first-in-human study to evaluate the safety, tolerability and performance of uncoated and placebo-coated Nanopatches
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
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
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Aged 18-45 years (inclusive).
- •2.Subject has a BMI within the range 18.0–30.0 kg/m2
- •3.Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical
- •history, physical examination, vital signs and laboratory evaluation (haematology or biochemistry)
- •4.Adequate venous access in their left or right arms to allow collection of a number of blood samples.
- •5.Subject is fair-skinned.
- •6.Subject is able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
- •7.Able and willing to provide written, personally signed and dated informed consent to participate in the study.
排除标准
- •1.Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions on both forearms and deltoid regions which could reasonably obscure application site reactions.
- •2.Known Predisposition to keloid scar formation.
- •3.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
- •4.History of malignancy, other than non-melanoma skin cancer.
- •5.An active medical condition that is under evaluation or treatment, or a recent illness, a chronic illness, an autoimmune disease or had major surgery within the last year.
- •6.History of Hepatitis B, Hepatitis C or HIV infection or clinical laboratory serology is positive for Hepatitis B surface antigen, Hepatitis C or HIV antibodies.
- •7.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation,
- •8.Receiving chronic treatment with immune-suppressive therapy (asthma inhalers and topical corticosteroids are permitted). All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee.
- •9.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study.
- •10.Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
- •11.Subject is pregnant or breast-feeding.
- •12.A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day.
- •13.Use of any prescription medication within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee.
- •14.Use of any investigational drug or device within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Day 0.
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