DRKS00020286已完成1 期
A multi-centre, open-label, phase 1 study, Part A single ascending dose and Part B multiple dose, to evaluate the safety, tolerability and pharmacokinetics, and to explore early signs of effectiveness of induction of antigen-specific immune tolerance with TPM203 in pemphigus vulgaris patients - TPV11
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Written informed consent to take part in the study;
- •2. Patient (male or female) age =18 years and =70 years;
- •3. Body weight of =50 kg and a body mass index =18.5 and =32 kg/m2;
- •4. Diagnosis with PV (documented), based on clinical symptoms, immune fluorescence; (skin/mucosa) and serum IgG (immunoglobulin G) against Dsg3 by ELISA;
- •5. At screening, complete clinical remission or low to moderate clinical disease activity (i.e. ABSIS =17 and PDAI =15);
- •6. Presence of anti-Dsg3 IgG antibodies in blood at screening;
- •7. Presence of peripheral blood CD4+ T cells specific for at least one of the Dsg3 peptides employed in TPM203 in blood samples at screening;
- •8. Agreement to contraception (applicable patients);
- •9. Negative result in a pregnancy test (applicable female patients).
- •10. Apart from PV, good general health.
排除标准
- •1. Immunosuppressive or immunomodulatory treatment during the study other than prednisolone =10 mg/d (or equipotent doses of other steroids);
- •2. Conditions including previous or concomitant medication that might present a risk to the patient and/or impede the attainment of the study's objectives.
研究者
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