NCT05411016进行中（未招募）1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient With Systemic Lupus Erythematosus, and Patient With Cutaneous Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
- 试验地点
- 23
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
Part 2 : To evaluate the safety and tolerability of repeated IV administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Outcomes Assessor: pharmacokinetic person, pharmacodynamic analysis person and investigational drug administration person are unblinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent to participate in the study
- •Japanese or non-Asian healthy men 18 to < 50 years at the time of informed consent
- •BMI 18.5 to < 30.0 at screening
- •Inclusion Criteria: Part 2
- •Voluntary written informed consent to participate in the study
- •Age 18 years to < 75 years at the time of informed consent
- •Weight over 40 kg and BMI 18.5 to < 35.0 at screening
- •Patients who meet any of the following criteria
- •Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening
- •Patients with CLE diagnosed by skin biopsy
排除标准
- •Current illness requiring treatment
- •History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.
- •History or of current drug allergy
- •Exclusion Criteria:Part2
- •Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria >0.5 g/24 h, pyuria (>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.)
- •Patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study.
- •Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent
- •Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KK4277
Experimental
干预措施: KK4277 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169
For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.
次要结局
- Profile of pharmacokinetics of serum KK4277 concentration(Part 1 : Day 1 (pre-dose, 0, 1, 6 hours after the start of administration), 2, 3, 4, 5, 6, 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, Part 2 :Enrollment, Day1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 141, 169)
- Time to the maximum concentration(Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169)
- The maximum concentration(Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169)
- Area under the concentration-time curve(Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169)
研究者
研究点 (23)
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