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RECRUITING
NCT07619157
PHASE1

A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus

Sponsor: Ono Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-02

Completion Date

2027-11-30

Last Updated

2026-06-08

Healthy Volunteers

Yes

Interventions

DRUG

ONO-3310

Single oral dose of ONO-3310 to HV

DRUG

Placebo

Single oral dose of Placebo to HV

DRUG

ONO-3310

Multiple oral dose of ONO-3310 to HV

DRUG

Placebo

Multiple oral dose of Placebo to HV

DRUG

ONO-3310

Single or multiple oral dose of ONO-3310 to CKD patients

Locations (1)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, Japan