A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study.
Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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/μL
- •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
研究组 & 干预措施
Part1 Dose 3P
Single administration
干预措施: Placebo IV/S (Drug)
Part1 Dose 4A
Single administration
干预措施: KHK4323 IV/S (Drug)
Part1 Dose 4P
Single administration
干预措施: Placebo IV/S (Drug)
Part1 Dose 5A
Single administration
干预措施: KHK4323 SC/S (Drug)
Part1 Dose 5P
Single administration
干预措施: Placebo SC/S (Drug)
Part1 Dose 6A
Single administration
干预措施: KHK4323 IV/S (Drug)
Part1 Dose 6P
Single administration
干预措施: Placebo IV/S (Drug)
Part1 Dose 7A
Single administration
干预措施: KHK4323 IV/S (Drug)
Part1 Dose 7P
Single administration
干预措施: Placebo IV/S (Drug)
Part2 Dose 1A
Multiple administration
干预措施: KHK4323 IV/M (Drug)
Part2 Dose 1P
Multiple administration
干预措施: Placebo IV/M (Drug)
Part2 Dose 2A
Multiple administration
干预措施: KHK4323 IV/M (Drug)
Part2 Dose 2P
Multiple administration
干预措施: Placebo IV/M (Drug)
Part1 Dose 1A
Single administration
干预措施: KHK4323 IV/S (Drug)
Part1 Dose 1P
Single administration
干预措施: Placebo IV/S (Drug)
Part1 Dose 2A
Single administration
干预措施: KHK4323 IV/S (Drug)
Part1 Dose 2P
Single administration
干预措施: Placebo IV/S (Drug)
Part1 Dose 3A
Single administration
干预措施: KHK4323 IV/S (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.
次要结局
- Profile of pharmacokinetics of serum KHK4323 concentration in Part 1(Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169)
- Profile of pharmacokinetics of serum KHK4323 concentration in Part 2(Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225)