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

ONO-3310-01:A Phase I Study 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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071260026

Enrollment

120

Registered

2026-05-12

Start date

2026-06-02

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

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 kidne

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety, Pharmacokinetics	—

Secondary

Measure	Time frame
Pharmacodynamics	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD.

clinical_trial@ono-pharma.com+81-120278120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jun 11, 2026