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A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ONO-3310 in Healthy Japanese Adult Male Subjects and Chronic Kidney Disease Patients with Type 2 Diabetes Mellitus

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic kidney disease
Date of first enrollment	02/06/2026
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	1) Single oral dose part ONO-3310 or placebo will be administered as a single oral dosing 2) Multiple oral dose part ONO-3310 or placebo will be administered as a multiple oral dosing 3) Chronic kidney disease part ONO-3310 will be administered as a single or multiple oral dosing

Outcome(s)

Primary Outcome	Safety, Pharmacokinetics
Secondary Outcome	Pharmacodynamics

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Both
Include criteria	Healthy Adult Part 1)Japanese healthy adult male subjects 2)Age at the time of informed consent: 18 to 45 years 3)BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2 Chronic Kidney Disease Patient Part 1)Chronic kidney disease patients with type 2 diabetes mellitus 2)Age at the time of informed consent: 18 to less than 65 years 3)UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g
Exclude criteria	Healthy adult part 1) 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. 2) Presence or history of severe allergy to drugs or food 3) Presence or history of drug or alcohol dependence Chronic kidney disease patient part 1) Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease 2) Patients with type 1 diabetes mellitus 3) Patients with a history of dialysis treatment