Type2 Diabetes MellitusPhase 1NCT07619157
A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing ONO-3310 in people with Type2 Diabetes Mellitus and Chronic Kidney Disease, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus, Chronic Kidney Disease
- What is being tested?
- ONO-3310
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- 2 Jun 2026to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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.
- Conditions
- Type2 Diabetes Mellitus, Chronic Kidney Disease
- Being tested
- ONO-3310, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-3310Drug
Single oral dose of ONO-3310 to HV
PlaceboDrug
Single oral dose of Placebo to HV
ONO-3310Drug
Multiple oral dose of ONO-3310 to HV
PlaceboDrug
Multiple oral dose of Placebo to HV
ONO-3310Drug
Single or multiple oral dose of ONO-3310 to CKD patients
| Study group | Role | What they receive |
|---|---|---|
| Single-dose ONO-3310 | Experimental | Not described Receives: Drug: ONO-3310 |
| Single-dose placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Multiple-dose ONO-3310 | Experimental | Not described Receives: Drug: ONO-3310 |
| Multiple-dose placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Single- and multiple-dose ONO-3310 | Experimental | Not described Receives: Drug: ONO-3310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Number of participants with adverse events
Measured: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)
Maximum plasma observed concentration (Cmax)
Measured: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Time to reach maximum observed concentration (Tmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Elimination half-life (T1/2)
Measured: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Apparent total clearance (CL/F)
Measured: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Urinary excretion rate of unchanged drug
Measured: Up to 6 days (HV single)
Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)
Measured: Up to 74 days (CKD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Jun 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619157
- Sponsor's protocol ID
- ONO-3310-01
- Other IDs
- jRCT2071260026
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07619157
- Acronym / sponsor ID
- ONO-3310-01
- Conditions
- Type2 Diabetes Mellitus, Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-3310Single oral dose of ONO-3310 to HV | Drug | Single-dose ONO-3310 |
| PlaceboSingle oral dose of Placebo to HV | Drug | Single-dose placebo |
| ONO-3310Multiple oral dose of ONO-3310 to HV | Drug | Multiple-dose ONO-3310 |
| PlaceboMultiple oral dose of Placebo to HV | Drug | Multiple-dose placebo |
| ONO-3310Single or multiple oral dose of ONO-3310 to CKD patients | Drug | Single- and multiple-dose ONO-3310 |
Primary outcome
Adverse event
Time frame: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)
Number of participants with adverse events
Maximum plasma observed concentration (Cmax)
Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Time to reach maximum observed concentration (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Elimination half-life (T1/2)
Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Apparent total clearance (CL/F)
Time frame: Up to 10 days (HV single), 23 days (HV multiple), and 74 days (CKD)
Urinary excretion rate of unchanged drug
Time frame: Up to 6 days (HV single)
Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)
Time frame: Up to 74 days (CKD)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-3310 in people with Type2 Diabetes Mellitus and Chronic Kidney Disease, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ono Pharmaceutical Co., Ltd. (+18665877745, clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: Through study completion, typically 10days (HV single), 23 days (HV multiple), and 74 days (CKD)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.