NCT07619157招募中1 期
A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
Ono Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes mellitus
详细描述
To investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects. In addition, in chronic kidney disease patients with type 2 diabetes mellitus, to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
In HV part, ONO-3310 or placebo will be administered in blinded manner. In CKD part, no masking will be conducted (open label).
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult part
- •Japanese healthy adult male subjects
- •Age at the time of informed consent: 18 to 45
- •BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m^2
- •Chronic kidney disease patient part
- •Chronic kidney disease patients with type 2 diabetes mellitus
- •Age at the time of informed consent: 18 to less than 65
- •UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g
排除标准
- •Healthy adult part
- •Subjects who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function.
- •Presence or history of severe allergy to drugs or food
- •Presence or history of drug or alcohol dependence
- •Chronic kidney disease patient part
- •Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease
- •Patients with type 1 diabetes mellitus
- •Patients with a history of dialysis treatment
研究者
研究点 (1)
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