CTIS2023-509555-13-00招募中1 期
Pharmacokinetic/pharmacodynamic evaluation of a single intravenous or subcutaneous dose of ublituximab in patients with multiple sclerosis - TG1101-RMS-SC101
Tg Therapeutics Inc.0 个研究点目标入组 60 人开始时间: 2024年1月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •18-65 years old, Diagnosis of RMS (2017 Revised McDonald criteria), Expanded Disability Status Scale (EDSS) score = 5.5 at screening, Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab
排除标准
- •Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS), Treatment with any investigational agent within 5 half-lives of the investigational drug, or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency), History of life-threatening injection/infusion related reaction (IRR), hypersensitivity, or anaphylactic reaction with anti-CD20 therapy, components of ublituximab solution or pre-treatment medications, Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV), History of serious opportunistic or atypical infections, including human immunodeficiency virus (HIV), History of active hepatitis B virus (HBV) as evidenced by a detectable hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA, History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML), Receipt of any live or live-attenuated vaccines (including vaccines for varicellazoster virus or measles) within 4 weeks prior to first study drug administration, Any severe or uncontrolled medical condition that could affect the participant’s ability to participate, Females who are pregnant or nursing, History of cancer except: - If considered likely to be cured (with supporting documentation from the treating oncologist if possible), - Is not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the Investigator, is not likely to require treatment in the ensuing 3 years, - Considered to have low probability of recurrence (with supporting documentation from the treating oncologist if possible), - Adequately treated and/or resolved basal or in situ squamous carcinomas of the skin are permitted, Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol., Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn’s disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.)
研究者
相似试验
已完成
不适用
The effect of body weight on rivaroxaban disposition in healthy human volunteersRivaroxaban disposition in healthy human volunteers (obese vs non-obese population)ISRCTN12520248Qatar University36
招募中
1 期
Single dose study of febuxostat (80 mg) in healthy subjects.Chronic goutMusculoskeletal - Other muscular and skeletal disordersACTRN12617001346369St Vincent's Hospital, Sydney10
进行中（未招募）
不适用
A Pilot Pharmacodynamic/Pharmacokinetic Study of SalmeterolXinofoate as a Dry Powder in Combination with Fluticasone in Patients with Asthma for Dose-Scale Bronchodilator Model Development.AsthmaMedDRA version: 12.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2010-018712-32-GBOriel Therapeutics Inc30
进行中（未招募）
1 期
Pharmacokinetic and pharmacodynamic evaluation of linezolid administered intravenously in MRSA-positive, morbidly obese patients with pneumonia.EUCTR2012-005127-33-BEniversity Ghent20
进行中（未招募）
不适用
Pharmacokinetic evaluation of a new formulation of recombinant factor IX (BeneFIX) in the italian population with severe or moderate B haemophilia previously treated. - NDPatients with severe or moderate B Haemophilia, previously treated with rFIX.MedDRA version: 9.1Level: SOCClassification code 10010331EUCTR2008-006465-85-ITAZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI