NCT03096223已完成1 期
A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects With Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
研究概览
简要总结
The objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions of KHK4083 in subjects with moderate or severe atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent to participate in the study
- •Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Dermatitis 2016) established by the Japanese Dermatological Association
- •Moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the Rajka & Langeland Severity Index
- •Investigator Global Assessment(IGA) ≥3 (moderate) at screening
排除标准
- •Any of the following clinically significant concurrent illnesses:
- •Type 1 diabetes
- •Poorly controlled type 2 diabetes (HbA1c >8.5%)
- •Congestive heart failure (class II to IV of the New York Heart Association classification)
- •Myocardial infarction within 1 year
- •Unstable angina pectoris within 1 year
- •Poorly controlled hypertension (systolic pressure >150 mm Hg or diastolic pressure >90 mm Hg at screening)
- •Severe chronic lung diseases requiring oxygen therapy
- •Multiple sclerosis or other demyelinating diseases
- •Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
- •Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
- •Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
- •Past or current history of drug allergy
- •Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
- •Any planned surgical treatment during the study
- •Any skin disease that may affect the clinical symptom assessment
- •Pregnant or lactating women, or women willing to have a child during the study period
研究组 & 干预措施
KHK4083
Experimental
干预措施: KHK4083 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
时间窗: Up to 22 weeks post drug administration
次要结局
- Area under the curve (AUC)(Up to 22 weeks post drug administration)
- Serum KHK4083 concentration(Up to 22 weeks post drug administration)
- Time to reach Cmax (tmax)(Up to 22 weeks post drug administration)
- Maximum concentration (Cmax)(Up to 22 weeks post drug administration)
- Anti-KHK4083 antibody production(Up to 22 weeks post drug administration)
研究者
研究点 (1)
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