EUCTR2020-001044-26-GB进行中（未招募）1 期
A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV) - An RSV Human Challenge Study of Palivizumab in Healthy Adult Participa
mAbxience Research S.L.0 个研究点目标入组 56 人开始时间: 2020年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
- •Please refer to Section 5.1 of the Protocol for full Inclusion criteria. Below is an abbreviated list:
- •1. Informed Consent
- •2. Aged between 18 and 55 years.
- •3. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), Electrocardiogram (ECG), and routine laboratory tests as determined by the Investigator.
- •4. A documented medical history prior to enrolment.
- •5. Females of childbearing potential must have a negative pregnancy test prior to enrolment.
- •6. Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 30 days after the date of viral challenge/last dosing with IMP (whichever occurs last).
- •b)Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 90 days after the date of Viral challenge / last dosing with the investigational medicinal product (IMP) (whichever occurs last).
- •c)Male participants must agree not to donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last).
- •7.For Part 2 of the study:
- •Sero-suitable to the challenge virus, as defined in the study Analytical Plan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Please refer to Section 5.2 of the Protocol for full Inclusion criteria. Below is an abbreviated list:
- •1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit.
- •2. a)Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
- •b)And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations.
- •3.Participants who have smoked = 10 pack years at any time [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]).
- •4.A total body weight = 50 kg and Body Mass Index (BMI) =18 kg/m2 and =30kg/m2.
- •5.Females who:
- •a)Are breastfeeding, or
- •b)Have been pregnant within 6 months prior to the study.
- •6.History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
- •7.Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- •8.a)For Part 2 of the study:Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
- •b)Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion.
- •c)Any nasal or sinus surgery within 3 months of the first study visit.
- •9.For Part 2 of the study:
- •a)Evidence of vaccinations within the 4 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
- •b)Intention to receive any vaccination(s) before the last day of Follow-up. (NB. No travel restrictions will apply after the Day 28 (±3 days) Follow-up Visit).
- •10.Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first) or planned during the 3 months after the final visit.
- •11.a)Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
- •b)Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
- •For Part 2 of the study:
- •c)Prior inoculation with a virus from the same virus-family as the challenge virus.
- •d)Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.
- •12. a)Confirmed positive test for drugs of abuse on first study visit. One repeat test allowed at PI discretion.
- •b)History or presence of alcohol addiction, or excessive use of alcohol, or excessive consumption of xanthine containing substances.
- •13. For Part 2 of the study:
- •A forced expiratory volume in 1 second (FEV1) < 80%.
- •14. Positi
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis- Associated PaiModerate to Severe Endometriosis Associated PainMedDRA version: 19.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872EUCTR2011-004295-11-GBAbbVie Deutschland GmbH & Co. KG815
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis- Associated PaiModerate to Severe Endometriosis Associated PainMedDRA version: 16.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872EUCTR2011-004295-11-ITAbbVie Deutschland GmbH & Co. KG815
进行中（未招募）
1 期
A study to investigate the mechanism of action and safety of Epeleuton capsules in the treatment of patients with type 2 diabetes and diabetic complicationsType 2 diabetes and diabetic complicationsMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disordersEUCTR2020-002911-23-DEAfimmune25
已完成
1 期
A Randomised, Double-Blind and Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIR9900 after Oral Administrations in Healthy Elderly Volunteers. (Multiple Ascending Dose (MAD), Part 2 Cohort 5).Inflammatory diseases, particularly in central nervous systemDegenerative diseases, particularly in central nervous systemInflammatory and Immune System - Other inflammatory or immune system disordersNeurological - Neurodegenerative diseasesACTRN12623000790640Sironax Aus Pty Ltd8
已完成
2 期
A Clinical trial to study the effect of an anti-diarrheal drug Crofelemer in patients with infectious diarrheaCTRI/2009/091/000361Glenmark Pharmaceuticals Ltd.80