EUCTR2013-004036-30-GB进行中（未招募）1 期
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model - Phase 2a, double blind, placebo-controlled, viral challenge study
Alios BioPharma0 个研究点开始时间: 2013年10月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Age 18 to 45 years, inclusive.
- •2. In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator.
- •3. A total body weight =50 kg and a BMI of >18. If the BMI is above 30 the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
- •4. Sexual history:
- •True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- •The following criteria are applicable to partners in a relationship where the partners are of the opposite sex (i.e. the criteria do not apply to those in a same sex relationship):
- •(a)Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to quarantine, and continuing until 90 days after dosing with IMP.
- •(b)In addition, male subjects must not donate sperm following discharge from quarantine until 90 days after dosing with IMP.
- •(c)Female subjects must:
- •- be post-menopausal females- defined as a history of amenorrhea for at least two years
- •- or have documented status as surgically sterile or post hysterectomy,
- •- if of childbearing potential, must have a negative blood pregnancy test at screening and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to quarantine and continuing until 90 days after dosing with IMP.
- •Acceptable forms of effective contraception include:
- •- Established (i.e. a minimum of 2 weeks prior to admission) use of oral, injected or implanted hormonal methods of contraception.
- •- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- •5. An informed consent document signed and dated by the subject and the Investigator.
- •6. Sero-suitable for the challenge virus
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Screening/Day -2 or Day -1 laboratory result outside the reference range .
- •Hemoglobin and reticulocyte counts = the lower limit of normal for healthy subjects.
- •a creatinine clearance < 50 mL/min
- •a Screening ALT or AST > 1.5 X ULN
- •2. Use/anticipated use during the study of concomitant medications, including vitamins or herbal and dietary supplements within the specified windows:
- •- Herbal supplements within 7 days before the first study drug dose
- •- Chronically used medications, vitamins or dietary supplements, including any medication known to be an inducer or inhibitor of CYP450 enzymes, within 21 days before the first dose.
- •- Over the counter medications (with the exception of infrequent use of NSAIDs (e.g., ibuprofen) or paracetamol) within 7 days before the first study drug dose (=3 g paracetamol or ibuprofen will be allowed prior to first study drug dose)
- •3. Subjects who are breastfeeding or who have been pregnant within 12 months prior to the study or who have a positive pregnancy test at any point during screening or prior to inoculation/dosing.
- •4. Any history or evidence of any clinically significant cardiovascular, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease.
- •a) Eczema/atopic dermatitis except subjects with clinically mild symptoms may be included
- •b) Psoriasis
- •c) Mild or moderate depressive episode(s) which occurred two or more years ago, with good evidence of preceding stressors and which resolved within approximately three months, may be included
- •Any concurrent serious illness that may interfere with a subject completing the study.
- •5. Abnormal pulmonary function
- •6. History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of eczema/atopic dermatitis
- •7. history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition
- •8. History of childhood asthma before the age of 12 years is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing after age 12 years can be included provided the episode is more than four years ago and did not require a hospital admission and/or oral steroids.
- •9. Positive human immunodeficiency virus, active hepatitis A, B, or C test.
- •10. Any significant abnormality altering the anatomy of the nose or nasopharynx.
- •11. Any clinically significant history of epistaxis
- •12. Any nasal or sinus surgery within six months of inoculation.
- •13. Recurrent history of fainting.
- •14. Twelve lead ECG recording with clinically relevant signs of pathology and conduction disturbances.
- •15. Confirmed positive test for drugs of abuse to be clinically significant.
- •16. Venous access deemed inadequate for the demands of the study.
- •17. Any known allergies to the excipients in the challenge virus inoculum.
- •18. Health care workers who work in units with severely immuno-compromised patients
- •19. Presence of household member or close contact who:
- •has known immunodeficiency
- •is receiving immunosuppressant medication
- •is undergoing or soon to undergo cancer chemotherapy
- •has been diagnosed with emphysema, COPD, or other severe lung disease
- •has received a bone marrow or solid organ transplant
- •resides in a nursing home.
- •20. •Evidence of vaccinations within the four weeks prior to inoculation/dosing.
- •Intention to receive any vaccination(s) before the Day 28 Follow Up V
研究者
相似试验
进行中（未招募）
1 期
A clinical trial of RV521 in healthy volunteersMedDRA version: 20.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestationsRespiratory Syncytial Virus InfectionEUCTR2017-001282-24-GBReViral Ltd66
进行中（未招募）
1 期
Respiratory Syncytial Virus challenge study of BTA-C585 in healthy volunteers.Respiratory Syncytial VirusEUCTR2015-004296-77-GBBiota Pharma Europe Limited60
进行中（未招募）
1 期
A clinical trial of EDP-938 in healthy volunteersMedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsRespiratory Syncytial Virus InfectionEUCTR2018-001878-21-GBENANTA Pharmaceuticals, Inc179
进行中（未招募）
1 期
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI 0382 is well tolerated.MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2018-000019-26-GBMedImmune Limited, a wholly owned subsidiary of AstraZeneca41
进行中（未招募）
1 期
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled AsthmaModerate-to-Severe Uncontrolled AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-003338-35-SKAstraZeneca AB666