ACTRN12619000599178已完成1 期
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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 75 Years（—）
- 性别
- All
入选标准
- •1. Male or female aged 18 to 75 years (inclusive) at screening;
- •2. Body mass index (BMI) of greater than 18.5 kg/m2 and less than 38 kg/m2 at screening;
- •3. History of plaque-type psoriasis for greater than or equal to 6 months;
- •4. Plaque-type psoriasis based on PASI score greater than or equal to 5 at both the screening and baseline visits;
排除标准
- •1. Presence of non-plaque psoriasis i.e., pustular, erythrodermic psoriasis;
- •2. Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments;
- •3. History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and medical monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
研究者
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