JPRN-jRCT2080224566终止1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects with Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 120
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •-Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
- •-BMI >= 18.5 to < 30.0 at time of screening tests
- •-Men and women aged 18 years or older at the time of consent
- •-Patients with EASI >= 16 in pre-administration testing
- •-Patients with IGA of 3: Moderate or higher in pre-administration testing
- •-Patients with BSA >= 10% at screening in pre-administration testing
排除标准
- •-Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
- •-Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
- •-Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
- •-Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
- •-Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
- •-Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period
- •-Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
- •-Patients observed to have one of the following laboratory test abnormalities in screening tests
- •Neutrophil count: < 1500/uL
- •Serum creatinine: > 1.5 mg/dL
- •AST or ALT: > 2.5-fold the upper limit of the reference range
- •Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial
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