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

NCT07619157 | Recruiting Phase 1

• 2 other identifiers: ONO-3310-01jRCT2071260026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type2 Diabetes Mellitus; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (5)

Single-dose ONO-3310

EXPERIMENTAL

Drug: ONO-3310

Single-dose placebo

PLACEBO COMPARATOR

Drug: Placebo

Multiple-dose ONO-3310

EXPERIMENTAL

Drug: ONO-3310

Multiple-dose placebo

PLACEBO COMPARATOR

Drug: Placebo

Single- and multiple-dose ONO-3310

EXPERIMENTAL

Drug: ONO-3310

Interventions

ONO-3310 DRUG

Single oral dose of ONO-3310 to HV

Single-dose ONO-3310

Placebo DRUG

Single oral dose of Placebo to HV

Single-dose placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult part
• Japanese healthy adult male subjects
• Age at the time of informed consent: 18 to 45
• BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m\^2
• Chronic kidney disease patient part
• Chronic kidney disease patients with type 2 diabetes mellitus
• Age at the time of informed consent: 18 to less than 65
• UACR measured by 24-hour urine collection: 300 mg/g to less than 3500 mg/g

You may not qualify if:

• Healthy adult part
• 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.
• Presence or history of severe allergy to drugs or food
• Presence or history of drug or alcohol dependence
• Chronic kidney disease patient part
• Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease
• Patients with type 1 diabetes mellitus
• Patients with a history of dialysis treatment

Sponsors & Collaborators

• Ono Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, Japan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Project Leader

  Ono Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Ono Pharmaceutical Co., Ltd.

CONTACT

+18665877745; clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777; clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: In HV part, ONO-3310 or placebo will be administered in blinded manner. In CKD part, no masking will be conducted (open label).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In healthy volunteer part, ONO-3310 or placebo will be administered in parallel. In CKD part, single- or multiple-dose of ONO-3310 will be administered same patient sequentialy.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 1, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)