Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
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
ONO-3310
Single oral dose of ONO-3310 to HV
Placebo
Single oral dose of Placebo to HV
ONO-3310
Multiple oral dose of ONO-3310 to HV
Placebo
Multiple oral dose of Placebo to HV
ONO-3310
Single or multiple oral dose of ONO-3310 to CKD patients
Locations (1)
Souseikai Hakata Clinic
Fukuoka, Fukuoka, Japan