ACTRN12622001387718终止1 期
A randomized, double-blind, placebo-controlled, phase 1, single centre, First-in-human, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single (SAD17442) and multiple (MAD17443) ascending, subcutaneous doses of SAR444559 in healthy adult participants.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Participants who are overtly healthy as determined by medical evaluation including medical/surgical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body weight within 50 to 100 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive).
- •A female participant not pregnant or breastfeeding, and one of the following conditions applies:
- •-- Is a woman of non-child-bearing potential (WONCBP) or
- •-- Is a woman of child-bearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective
- •Male participants who agree to refrain from donating and cryopreservating sperm
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •-History or presence of cardiovascular, respiratory (excluding fully resolved childhood asthma with no history of hospitalization), hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- •- Significant ocular disease including but not limited to any history of glaucoma, any retinal pathology or history of retinal issues including retinal tears/holes/detachment, history of ocular inflammation/uveitis, moderate/severe refractive errors, pathologic gonioscopy result, and shallow anterior chamber.
- •-Live vaccines: Last administration of a vaccine within 3 months before randomization.
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 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: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-002480-26-ESovartis Farmacéutica S.A.244