Diabetic Kidney DiseasePhase 1NCT06666283
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
A Phase 1 study testing AP303 150μg in people with Diabetic Kidney Disease, run by Alebund Pharmaceuticals at 1 site in China.
Trial summary
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- AP303 150μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 25 Sep 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants, ≥30 years of age at the time of signing the informed consent form.
- BMI (body mass index) 18-30 kg/m².
- Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
- Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
- Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.
- Estimated GFR ≥30 mL/min/1.73m² but < 60 mL/min/1.73m² at the screening visit.
- Urinary albumin to creatinine ratio ≥ 30 mg/g at the screening visit.
Who cannot join
- Chronic kidney disease other than type 2 diabetic kidney disease.
- Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
- Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
- Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
- Peripheral edema above the ankle level at the screening or randomization visit.
- Confirmed (based on the average of 2 separate resting blood pressure measurements in a sitting position, after at least 5 minutes rest) systolic BP greater than 160 or less than 90 mmHg, and diastolic BP greater than 100 or less than 50 mmHg at screening.
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- Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack, cardiovascular surgery within 6 months prior to the screening visit.
- Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG: e.g.
- QTc interval (QTcF > 450 ms for male and QTcF > 470 ms for female) based on the average interval on triplicate ECGs obtained after 5 minute's rest in a supine position
- Notable resting bradycardia (mean HR < 40 bpm)
- Notable resting tachycardia (mean HR > 100 bpm)
- ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves)
- Any other significant abnormality
- Implantation of cardiac pacemaker or clinically significant arrhythmia, e.g. atrial fibrillation, atrial flutter, right or left bundle branch block, Wolf-Parkinson-White Syndrome.
- Current or previous treatment with a thiazolidinedione (e.g., medications containing pioglitazone or rosiglitazone, like Actos, Avandia, ActoplusMet, Avandamet, Avandaryl), PPARa agonist (like fenofibrate) or any dual/multiple PPARa/g agonist (e.g., Chiglitazar Sodium) in the 3 months preceding screening visit.
- Previous treatment with CYP2C8 inducer or strong/moderate inhibitor (refer to the list in Appendix 4) in the 1 month preceding screening visit.
- Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs) (except prophylactic stable low dose aspirin, defined as its dose not higher than 100 mg daily; paracetamol/acetaminophen was allowed) in the last month before screening.
- ALT or AST >1.5 × ULN, or laboratory tests revealed other clinically significant abnormalities in liver function at screening.
- Creatine phosphokinase (CPK) elevated > 3 x ULN at screening visit or history of drug-induced myopathy.
- History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).
- Participants who have had significant acute infection, e.g., COVID-19, influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks before study drug administration.
- Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb), human immunodeficiency virus (HIV Ab) or syphilis AB.
- Dosed with a small-molecule investigational drug within 3 months, or biologic investigational drug within 3 months or 5 half-lives (whichever is the longer) prior to first dose of this study.
- History of drug and/or alcohol abuse or addiction. History (within 3 months of screening) of alcohol consumption exceeding 3 and 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol) for male and female, respectively.
- Within 2 weeks prior to admission, use of >5 cigarettes or equivalent nicotine-containing product per day.
- Medical or social conditions that would potentially interfere with the participant's ability to comply with the study visit schedule or the study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100009
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Diabetic Kidney Disease Patients With Renal Impairment.
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
Read the detailed description
Eligible patients will be enrolled into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at a 2:1 ratio (6 on AP303 and 3 on placebo).
- Conditions
- Diabetic Kidney Disease
- Being tested
- AP303 150μg, Placebo 150μg
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP303 150μgDrug
AP303 Tablet 150μg QD
Placebo 150μgDrug
Placebo Tablet 150μg QD
| Study group | Role | What they receive |
|---|---|---|
| AP303 | Experimental | Not described Receives: Drug: AP303 150μg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo 150μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: Day 1, Day 14
Tmax
Time to maximum observed plasma concentration
Measured: Day 1, Day 14
AUC0-24h
Area under the plasma concentration versus time curve up to 24 hours
Measured: Day 1
AUC0-last
Area under the plasma concentration versus time curve up to the last measurable concentration
Measured: Day 1
AUC0-inf
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Day 1
AUC0-t
Area under the plasma concentration-time curve for a dosing interval
Measured: Day 14
t1/2
Apparent terminal half-life, computed as ln(2)/λz
Measured: Day 1, Day 14
CL/F
Apparent oral clearance calculated from Dose/ AUC0-inf
Measured: Day 1
V/F
Apparent volume of distribution of oral drug
Measured: Day 1, Day 14
Cav
Average plasma concentration
Measured: Day 14
Ctrough
Trough plasma concentration
Measured: Day 3-14
Rac
Ratio of accumulation
Measured: Day 3-14
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Day 1-28
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Measured: Day 1-28
Effect of AP303 on ECG parameters
Change of Heart rate in beats/min
Measured: Day 1-28
Effect of AP303 on ECG parameters
change of QT in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
Change of PR in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
Change of QRS in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
Change of QTcF in ms
Measured: Day 1-28
Effect of AP303 on ECG parameters
Change of QTcB in ms
Measured: Day 1-28
Vital signs（Systolic blood pressure）
Change of systolic blood pressure
Measured: Day 1-28
Effect of AP303 on physical examination result
Number of pariticipants with abnormal physical examination findings by nature and severity
Measured: Day 1-28
Body weight
Change of body weight
Measured: Day 1-28
Vital signs (Diastolic blood pressure)
Change of diastolic blood pressure
Measured: Day1-28
Vitlal signs (Body temperature)
Change of body temperature
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal QTcB.
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal QTcF
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal QRS
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal PR
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal QT
Measured: Day 1-28
Effect of AP303 on ECG parameters
Number of participants with abnormal heart rate
Measured: Day 1-28
Secondary outcomes (4)
Fasting glucose
Change of fasting glucose
Measured: Baseline, Days 6, 10, 14 and 28
Fasting lipid profile
Change of Triglyceride, HDL-C, LDL-C, Total cholesterol
Measured: Baseline, Days 6, 10, 14 and 28
Serum creatinine
Change of serum creatinine
Measured: Baseline, Days 6, 10, 14 and 28
eGFR
Change of estimated glomerular filtration rate
Measured: Baseline, Days 6, 10, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start27 Feb 2025
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alebund Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, Principal investigator, Peking University First HospitalYing Gao, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666283
- Sponsor's protocol ID
- AP303-PK-03
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Diabetic Kidney Disease Patients With Renal Impairment.
- ClinicalTrials.gov ID
- NCT06666283
- Acronym / sponsor ID
- AP303-PK-03
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Alebund PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 30 Oct 2024 (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.
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
Detailed description
Eligible patients will be enrolled into one of the two dose cohorts, each cohort will include 9 participants randomized to AP303 and placebo at a 2:1 ratio (6 on AP303 and 3 on placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP303 | Experimental | Drug: AP303 150μg |
| Placebo | Placebo comparator | Drug: Placebo 150μg |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female participants, ≥30 years of age at the time of signing the informed consent form.
- BMI (body mass index) 18-30 kg/m².
- Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
- Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
- Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.
Key exclusion criteria (26 listed)
- Chronic kidney disease other than type 2 diabetic kidney disease.
- Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
- Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
- Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
- Peripheral edema above the ankle level at the screening or randomization visit.
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 |
|---|---|---|
| AP303 150μgAP303 Tablet 150μg QD | Drug | AP303 |
| Placebo 150μgPlacebo Tablet 150μg QD | Drug | Placebo |
Primary outcome
Cmax
Time frame: Day 1, Day 14
Maximum observed plasma concentration
Tmax
Time frame: Day 1, Day 14
Time to maximum observed plasma concentration
AUC0-24h
Time frame: Day 1
Area under the plasma concentration versus time curve up to 24 hours
AUC0-last
Time frame: Day 1
Area under the plasma concentration versus time curve up to the last measurable concentration
AUC0-inf
Time frame: Day 1
Area under the plasma concentration versus time curve extrapolated to infinity
AUC0-t
Time frame: Day 14
Area under the plasma concentration-time curve for a dosing interval
t1/2
Time frame: Day 1, Day 14
Apparent terminal half-life, computed as ln(2)/λz
CL/F
Time frame: Day 1
Apparent oral clearance calculated from Dose/ AUC0-inf
V/F
Time frame: Day 1, Day 14
Apparent volume of distribution of oral drug
Cav
Time frame: Day 14
Average plasma concentration
Ctrough
Time frame: Day 3-14
Trough plasma concentration
Rac
Time frame: Day 3-14
Ratio of accumulation
Incidence and severity of adverse events
Time frame: Day 1-28
Incidence and severity of adverse events
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Time frame: Day 1-28
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Change of Heart rate in beats/min
Effect of AP303 on ECG parameters
Time frame: Day 1-28
change of QT in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Change of PR in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Change of QRS in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Change of QTcF in ms
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Change of QTcB in ms
Vital signs（Systolic blood pressure）
Time frame: Day 1-28
Change of systolic blood pressure
Effect of AP303 on physical examination result
Time frame: Day 1-28
Number of pariticipants with abnormal physical examination findings by nature and severity
Body weight
Time frame: Day 1-28
Change of body weight
Vital signs (Diastolic blood pressure)
Time frame: Day1-28
Change of diastolic blood pressure
Vitlal signs (Body temperature)
Time frame: Day 1-28
Change of body temperature
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal QTcB.
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal QTcF
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal QRS
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal PR
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal QT
Effect of AP303 on ECG parameters
Time frame: Day 1-28
Number of participants with abnormal heart rate
4 secondary outcomes
Fasting glucose
Time frame: Baseline, Days 6, 10, 14 and 28
Fasting lipid profile
Time frame: Baseline, Days 6, 10, 14 and 28
Serum creatinine
Time frame: Baseline, Days 6, 10, 14 and 28
eGFR
Time frame: Baseline, Days 6, 10, 14 and 28
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 11 Sep 2025.
- 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.
Hong Zhang principal investigator
Peking University First Hospital
Ying Gao principal investigator
Peking University First Hospital
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 AP303 150μg in people with Diabetic Kidney Disease, run by Alebund Pharmaceuticals at 1 site in China.
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 7 inclusion and 26 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 11 Sep 2025. 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 China. 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 Yuran Zhang (+8613661548603, yuran.zhang@alebund.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 1, Day 14). The study lists 31 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 11 Sep 2025.