ACTRN12616000880448已完成1 期
A first-in-human study to evaluate the safety tolerability and performance of A/California/7/2009 (H1N1)- like vaccine coated Nanopatches in comparison to placebo coated Nanopatches and intramuscular injection of A/California/7/2009 (H1N1)-like vaccine.. Nanopatches will be delivered to skin using an applicator device (CAPD). The study involves healthy adults.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
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
- Prevention
- 盲法
- Blinded (masking 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 Body Mass Index (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 (skin type I, II or III, according to the Fitzpatrick scale).
- •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 anaphylactic hypersensitivity to a previous influenza vaccination or to eggs, neomycin, polymyxin B sulphate or any of the constituents or trace residues of the study vaccine.
- •3.Has received an influenza vaccine or has been diagnosed by a doctor as having influenza in the last 12 months.
- •4.Known history of Guillain-Barre syndrome.
- •5.Recent vaccination (within 30 days prior to enrollment) with any vaccine.
- •6.Known Predisposition to keloid scar formation.
- •7.History of granulomatous diseases (especially sarcoidosis and granuloma annulare).
- •8.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
- •9.History of malignancy, other than non-melanoma skin cancer.
- •10.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.
- •11.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.
- •12.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation,
- •13.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.
- •14.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study.
- •15.Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
- •16.Subject is pregnant or breast-feeding.
- •17.A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day.
- •18.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.
- •19.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.
- •20.Previous exposure to the Nanopatch and its applicator
研究者
相似试验
已完成
不适用
A first-in-human study to evaluate the safety and performance of placebo excipient-coated high-density microarray patches applied by an integrated application device.VaccinationsPublic Health - Other public healthACTRN12620000179932Vaxxas Pty Ltd43
已完成
2 期
A first-in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome (CBPR277X2101)Netherton syndrome10040790NL-OMON40034ovartis Pharma BV5
进行中（未招募）
不适用
CBPR277X2101Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS)MedDRA version: 14.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858MedDRA version: 14.1Level: PTClassification code 10062909Term: Netherton's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-000917-38-DEovartis Pharma Services AG85
进行中（未招募）
不适用
CBPR277X2101EUCTR2011-000917-38-NLovartis Pharma Services AG85
进行中（未招募）
1 期
Study to evaluate QR-421a in subjects with retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A GeneEUCTR2018-002433-38-FRProQR Therapeutics18