ONO-3310 safety test in healthy men and adults with CKD and type 2 diabetes
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
Run by Ono Pharmaceutical Co., Ltd. · NCT07619157 · Data updated 2026-11-12
This early-phase study tests whether ONO-3310 is safe and well tolerated in healthy Japanese men and in adults with chronic kidney disease and type 2 diabetes, using single and multiple oral doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Fukuoka, Fukuoka) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT07619157 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy Japanese men aged 18–45 with normal BMI or CKD patients aged 18–64 with type 2 diabetes and UACR 300–3499 mg/g.
✕Probably not a fit
Patients who do not fit the eligibility criteria or who have uncontrolled health conditions may not benefit and could be excluded from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial investigates the safety, tolerability, pharmacokinetics, and pharmacodynamics of ONO-3310 given as single and multiple oral doses. It includes two groups: healthy Japanese adult males and CKD patients with type 2 diabetes mellitus. Participants receive ONO-3310 or placebo in a controlled setting to understand how the drug behaves in the body and its immediate effects. The study will help determine appropriate dose ranges for future trials and identify any dose-limiting safety concerns.
Why it matters
Potential benefit: If successful, participants may experience minimal direct benefit, while data could support dose guidelines for future research.
How similar studies have gone: Prior Phase 1 trials in healthy individuals and patients with related conditions have informed safety and pharmacokinetic profiles of similar compounds; the novelty here lies in including CKD patients with diabetes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Souseikai Hakata Clinic
Fukuoka, Fukuoka, Japan Recruiting
Study contacts
- Study coordinator: Ono Pharmaceutical Co., Ltd.
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.