EUCTR2010-021193-11-GB进行中（未招募）不适用
A randomised, open-labelled, multiple dose study of HT61 formulations applied to the anterior nares plus chlorhexidine body and hair washes in subjects with nasal carriage of Staphylococcus aureus - Multiple doses of HT61 formulations in Staph aureus carriers
Helperby Thearapeutics Ltd0 个研究点目标入组 33 人开始时间: 2010年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female between 18 to 85 years inclusive.
- •2. Judged healthy from a medical history, routine laboratory investigations, vital signs and ECGs.
- •3. Capable of giving informed consent.
- •4. Able to understand, willing and likely to fully comply with study procedures and restrictions.
- •5. Able to attend all visits and complete the study.
- •6. Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e. surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to
- •dosing or naturally postmenopausal for at least one year with a Screening FSH level =40mlU/L). A negative serum pregnancy test is required at Screening for females.
- •Female subjects
- •Female subjects of childbearing potential must use medically acceptable methods of contraception from the time of the first administration of the study medication until three months following administration of the last application of study medication. Acceptable methods include:
- •. Oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or sub-dermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}
- •. A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}
- •. Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}
- •. Documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlu-sive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used
- •. Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •. Abstinence
- •Male subjects
- •Male subjects must use medically acceptable methods of contraception if their female partners are pregnant from the time of the first administration of the study medication until 3 months following administration of the last application of
- •study medication. Acceptable methods include:
- •. If the subject has undergone surgical sterilisation (vasectomy with documentation of azoosper-mia) a condom with spermicidal foam/gel/film/cream/suppository should also be used
- •. Use acceptable methods of contraception if the male subject's partner could become pregnant from the time of the first administration of study medication until three months following administration of the last application of study medication. The acceptable methods of contraception are as follows:
- •. Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •. Surgical sterilisation (vasectomy with documentation of azoospermia) and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}
- •. The female partner uses oral contraceptives (combination estrogen/progesterone pills), in-jectable progesterone or subdermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}
- •. Medically prescrib
排除标准
- •1. Any allergic reactions to mupirocin or glycine ester.
- •2. Any clinically significant skin or other condition or disorder which may affect the conduct or outcome of the study.
- •3. Clinical significant signs of infected skin diseases, e.g. infected Eczema.
- •4. Carriage of either methicillin sensitive or resistant Staphylococcus aureas in the throat or skin/wound lesion.
- •5. Abnormal pathology of nasal passages.
- •6. Any clinically significant allergy or drug intolerance.
- •7. Active hay fever, on-going cold/flu symptoms, including rhinitis.
- •8. Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics.
- •9. Any medical history or renal insufficiency or hepatic disorder.
- •10. Any history of history of pet ownership.
- •11. Are living with children under the age of 10.
- •12. History or signs or symptoms of any cancer.
- •13. Participation in a study with an investigational drug within 90 days prior to study drug application on Day 1.
- •14. History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units. One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine.
- •15. Subjects with known or suspected immunodeficiency.
- •16. Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit.
- •17. Subjects who have received treatment with any non–marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to baseline visit.
- •18. History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, or neurological disease.
- •19. A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.
- •20. Blood donation or blood loss of more than 600 ml within 90 days prior to dosing on Day 1.
- •21. Known or suspected drug abuse.
研究者
相似试验
已完成
1 期
A study in healthy male volunteers to investigate how the test medicine is taken up, broken down and removed from the bodyNervous System DiseasesEpilepsyISRCTN21667877Supernus Pharmaceuticals (United States)8
进行中（未招募）
不适用
A phase I multiple dose pharmacokinetic study of nevirapine extended release (XR) in HIV-1 infected children.EUCTR2008-005855-61-Outside-EU/EEABoehringer Ingelheim (Pty) Ltd75
进行中（未招募）
不适用
Study to investigate the behaviour and properties of nevirapine extended release tablets in humans when given to children who are infected with HIV-1, with an optional extension phase.HIV-1 infected children under antiretroviral therapyEUCTR2008-005855-61-DEBoehringer Ingelheim Pharma GmbH & Co. KG75
进行中（未招募）
不适用
An open-label, multiple-dose study to evaluate the pharmacokinetics, safety and tolerability of SPP100 (Aliskiren) and Atenolol (Tenormin®) administered alone and in combination in healthy subjectsHypertensionEUCTR2005-001252-21-DEovartis Pharma Services AG
进行中（未招募）
不适用
A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.Anemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysisMedDRA version: 17.0Level: LLTClassification code 10058124Term: Nephrogenic anemiaSystem Organ Class: 100000004851EUCTR2007-007758-70-HUF. Hoffmann-La Roche Ltd68