EUCTR2013-001983-52-GB进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, phase 2a study in healthy volunteers, to evaluate the efficacy and safety of MHAA4549A in an Influenza challenge model
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
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
入选标准
- •- In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests
- •- Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit
- •- Sero-suitable for 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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study
- •- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI
- •- Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry
- •- History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.
- •- History suggestive of respiratory infection within 14 days prior to admission to the unit
研究者
相似试验
进行中（未招募）
1 期
Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with a genetically distinct subtype of unresectable or metastatic melanoma, which is characterised by a mutation in the BRAF genenresectable or metastatic BRAF V600 mutant melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2016-002794-35-ITOVARTIS PHARMA AG538
进行中（未招募）
不适用
A comparison of brentuximab vedotin and CHP with standard-of-care CHOP in the treatment of patients with CD30-positive mature T-cell lymphomasCD30-positive mature T-cell lymphomasMedDRA version: 14.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2012-002751-42-ITSeattle Genetics, Inc.300
进行中（未招募）
1 期
16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisMedDRA version: 17.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersAnkylosing SpondylitisEUCTR2013-005575-41-ESovartis Farmacéutica, S.A.324
进行中（未招募）
1 期
Study of efficacy and safety of canakinumab in combination with docetaxel in subjects with non-small cell lung cancers as a second or third line therapy.on-small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002480-26-ITOVARTIS PHARMA AG245
进行中（未招募）
1 期
Study of safety and efficacy of PDR001 in combination with dabrafenib and trametinib in patients with a genetically distinct subtype of unresectable or metastatic melanoma, which is characterised by a mutation in the BRAF genenresectable or metastatic BRAF V600 mutant melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2016-002794-35-PTovartis Pharma AG538