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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: ONO-3310; Drug: ONO-3310; Drug: ONO-3310; Drug: Placebo; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ono Pharmaceutical Co., Ltd.; Phone Number: +18665877745; Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777; Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Fukuoka
    • Fukuoka, Fukuoka, Japan
      • Recruiting
      • SOUSEIKAI Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy adult part

1. Japanese healthy adult male subjects
2. Age at the time of informed consent: 18 to 45
3. BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m^2

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
3. UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-dose ONO-3310	Drug: ONO-3310; Single oral dose of ONO-3310 to HV; Drug: ONO-3310; Multiple oral dose of ONO-3310 to HV; Drug: ONO-3310; Single or multiple oral dose of ONO-3310 to CKD patients
Placebo Comparator: Single-dose placebo	Drug: Placebo; Single oral dose of Placebo to HV; Drug: Placebo; Multiple oral dose of Placebo to HV
Experimental: Multiple-dose ONO-3310	Drug: ONO-3310; Single oral dose of ONO-3310 to HV; Drug: ONO-3310; Multiple oral dose of ONO-3310 to HV; Drug: ONO-3310; Single or multiple oral dose of ONO-3310 to CKD patients
Placebo Comparator: Multiple-dose placebo	Drug: Placebo; Single oral dose of Placebo to HV; Drug: Placebo; Multiple oral dose of Placebo to HV
Experimental: Single- and multiple-dose ONO-3310	Drug: ONO-3310; Single oral dose of ONO-3310 to HV; Drug: ONO-3310; Multiple oral dose of ONO-3310 to HV; Drug: ONO-3310; Single or multiple oral dose of ONO-3310 to CKD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Number of participants with adverse events	Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)
Maximum plasma observed concentration (Cmax)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Time to reach maximum observed concentration (Tmax)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24h)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUClast)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Elimination half-life (T1/2)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Apparent total clearance (CL/F)		Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Urinary excretion rate of unchanged drug		Up to 6 days (HV single)
Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)		Up to 74 days (CKD)

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co., Ltd.
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: ONO-3310-01; jRCT2071260026 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No