EUCTR2020-000067-23-GB进行中（未招募）1 期
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •Age between 18 and 80 years, male and female.
- •Patient with a confirmed diagnosis of monoclonal IgM associated with monoclonal gammopathy of undetermined significance (MGUS) with anti-MAG activity (titer of > 10’000 Bühlmann Titer units (BTU) and demyelinating neuropathy defined by electrophysiological criteria according to European Federation of Neurological Societies/Peripheral Nervous System paraproteinemic demyelinating neuropathy EFNS/PNS PDN guideline, 2010.
- •Clear clinical signs of disability: with at least ONLS = 2 in lower extremities.
- •Inflammatory Neuropathy Cause and Treatment sensory sum score (ISS) =2.
- •Adequate hepatic and renal function
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Patients with total serum IgM levels >30 g.
- •Hematological malignancy, prior malignancy of any organ system (except BCC)
- •Previous immunosuppressive treatment with intravenous immunoglobulin (IVIG) or apheresis/plasmapheresis in the preceeding 3 months, and cyclophosphamide and/or biologicals (e.g. rituximab): in the preceeding 6 months prior to enrolment
- •Other neurological, neuromuscular, rheumatologic or orthopedic conditions with significant impact on the capability of walking preventing evaluation of neurological scores
研究者
相似试验
进行中（未招募）
1 期
First in human study to test the safety and preliminary efficacy of PPSGG, an antibody catcher in patients with anti-MAG neuropathyEUCTR2020-000067-23-FRPolyneuron Pharmaceuticals AG48
已完成
1 期
First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NOX-H94MedDRA - LLT 10002272 (Anämie / Anemia)D63Anaemia in chronic diseases classified elsewhereDRKS00003102OXXON Pharma AG64
进行中（未招募）
1 期
A study in healthy male volunteers to look at the safety and tolerability of the new test medicine GUB014295 and how it is taken up by the body when given as a single dose by injectioControlling obesityNutritional, Metabolic, EndocrineISRCTN85112396Gubra A/S48
已完成
1 期
First in man study to evaluate the safety, tolerability and preliminary efficacy of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia patients with minimal residual diseaseC92.0Acute myeloblastic leukaemia [AML]DRKS00011887Synimmune GmbH31
招募中
不适用
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimer's DiseasedementiaNL-OMON56092ImmunoBrain Checkpoint, Inc6