NCT06823947招募中1 期
A Phase 1, Placebo-Controlled, Double-Blind, Randomized, Single and Multiple Ascending-Dose Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 3
- 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 of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary consent to participate in this study must be given (in writing)
- •Japanese healthy adults or non-Asian healthy men 18 to < 55 years at the time of informed consent ( Japanese healthy adults 65 to < 80 years for the elderly cohort)
- •BMI is within the specified range at screening
- •Inclusion Criteria: Part 2
- •Voluntary consent to participate in this study must be given (in writing)
- •Japanese patients with essential hypertension, aged 18 to <65 years at the time of informed consent
- •BMI is within the specified range at screening
- •Inclusion Criteria: Part 3
- •Voluntary consent to participate in this study must be given (in writing)
- •Japanese patients with essential hypertension, aged 18 to <80 years at the time of informed consent
- •BMI is within the specified range at screening
排除标准
- •History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- •History of or current drug allergy
- •History of or current alcoholism or drug addiction
- •Smoking within the specified period
- •infection within the specified period
- •Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
- •Exclusion Criteria: Part 2
- •History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- •History or of current drug allergy
- •History of or current alcoholism or drug addiction
- •Pregnant or breastfeeding patients, or patients willing to have a child during the study
- •Smoking within the specified period
- •infection within the specified period
- •Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
- •Exclusion Criteria: Part 3
- •History of any respiratory disease, heart disease, gastrointestinal disease, renal disease, liver disease, psychiatric disorder, autoimmune disease, or malignant tumor that may affect assessments in the study, as judged by principal investigator or subinvestigator.
- •History or of current drug allergy
- •History of or current alcoholism or drug addiction
- •Pregnant or breastfeeding patients, or patients willing to have a child during the study
- •Smoking within the specified period
- •infection within the specified period
- •Any condition judged by the investigator or subinvestigator to be unsuitable for participation in the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KK3910
Experimental
干预措施: KK3910 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Part 1 : Day 1 to Day 85, Part 2: Day 1 to Day 155, Part 3: Day 1 to Day 155
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
- Time to the maximum concentration(Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155)
- The maximum concentration(Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155)
- Area under the concentration-Time curve(Part 1 : Day 1 to Day 85, Part 2 : Day 1 to Day 155, Part 3: Day 1 to Day 155)
研究者
研究点 (3)
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