Type 2 Diabetes MellitusPhase 1NCT06422039
Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects
A Phase 1 study testing HRS-7535(D) Tablets and HRS-7535(C) Tablets in people with Type 2 Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HRS-7535(D) Tablets and HRS-7535(C) Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2024to 6 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide a written informed consent;
- Male or female aged 18-45 at screening (both inclusive);
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
- Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.
Who cannot join
- Those who had a smoking history in the 3 months before screening (average daily smoking > 5 cigarettes), or could not stop using any tobacco products during the test;
- Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
- Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
- Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
- A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
- A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
Show all 18Show fewer
- Abnormalities with QTcF > 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant;
- Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant;
- Positive hepatitis B surface antigen (HBsAg), positive antibodies against hepatitis C virus (HCV), positive antibodies against human immunodeficiency virus (HIV), or positive antibodies against syphilis within 4 weeks prior to screening;
- Use of any prescription, over-the-counter, herbal or dietary supplements (excluding regular vitamins) in the 2 weeks prior to screening;
- Participants in clinical trials of any other drug or medical device within the 3 months prior to screening or within the 5 half-life of the drug (based on whether the drug was administered or used, excluding placebo);
- Received BCG vaccine within 12 months prior to screening; Vaccination or exposure to other live or attenuated vaccines (other than COVID-19 vaccines) within 3 months prior to screening; Or who plan to be vaccinated during the trial;
- Patients who have had any surgery in the 3 months prior to screening, have not recovered from surgery, or are likely to have surgery or hospitalization plans during the trial period;
- Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion;
- Positive results of serum pregnancy test (serum beta-HCG test) during screening period or baseline examination in women;
- The woman had any form of pregnancy (including spontaneous abortion, delivery, ectopic pregnancy, etc.) in the 3 months prior to the screening, or was breastfeeding at the time of the screening visit;
- Women use the following contraceptive methods during screening visits: medicated extended-release Iuds, extended-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsules); Use of long-acting contraceptive injections before screening (medroxyprogesterone acetate should be prohibited 3 months before screening, other injections should be prohibited 1 month before screening), use of oral contraceptives 2 months before screening, and use of contraceptive patches 1 month before screening; Special cases are judged by the researcher;
- Subjects have conditions that, as determined by the investigator, affect drug absorption, distribution, metabolism, and excretion, or reduce adherence, or other factors that make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Relative Bioavailability of HRS-7535 Tablets of Different Formulating Processes and the Effects of Food on New Formulates (Single Center, Random, Open, Cross)
This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HRS-7535(D) Tablets, HRS-7535(C) Tablets
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535(D) TabletsDrug
One HRS-7535(D) Tablet is administered to healthy subjects.
HRS-7535(C) TabletsDrug
Two HRS-7535(C) Tablets is administered to healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HRS-7535(D) Tablets; Drug: HRS-7535(C) Tablets |
| Treatment group B | Experimental | Not described Receives: Drug: HRS-7535(D) Tablets; Drug: HRS-7535(C) Tablets |
| Treatment group C | Experimental | Not described Receives: Drug: HRS-7535(D) Tablets; Drug: HRS-7535(C) Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters：Cmax
Measured: 0 hour to 72 hours after the last dosing
PK parameters：AUC0-t
Measured: 0 hour to 72 hours after the last dosing
PK parameters：AUC0-∞
Measured: 0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal
Measured: 0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status
Measured: 0 hour to 72 hours after the last dosing
Secondary outcomes (5)
PK parameters：Tmax
Measured: 0 hour to 72 hours after the last dosing
PK parameters： t1/2
Measured: 0 hour to 72 hours after the last dosing
PK parameters： CL/F
Measured: 0 hour to 72 hours after the last dosing
PK parameters： V/F
Measured: 0 hour to 72 hours after the last dosing
Incidence and severity of adverse events (AEs)
Measured: from screening to 72 hours after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start23 May 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- Randomised
- Intervention model
- Crossover
- Model description
- This study was an open, fixed-sequence clinical trial in healthy adult subjects
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422039
- Sponsor's protocol ID
- HRS-7535-103
- Status last verified
- Apr 2026
- First submitted
- 14 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Relative Bioavailability of HRS-7535 Tablets of Different Formulating Processes and the Effects of Food on New Formulates (Single Center, Random, Open, Cross)
- ClinicalTrials.gov ID
- NCT06422039
- Acronym / sponsor ID
- HRS-7535-103
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 20 May 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.
This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study was an open, fixed-sequence clinical trial in healthy adult subjects
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS-7535(D) Tablets, Drug: HRS-7535(C) Tablets |
| Treatment group B | Experimental | Drug: HRS-7535(D) Tablets, Drug: HRS-7535(C) Tablets |
| Treatment group C | Experimental | Drug: HRS-7535(D) Tablets, Drug: HRS-7535(C) Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able and willing to provide a written informed consent;
- Male or female aged 18-45 at screening (both inclusive);
- Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
- Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.
Key exclusion criteria (18 listed)
- Those who had a smoking history in the 3 months before screening (average daily smoking > 5 cigarettes), or could not stop using any tobacco products during the test;
- Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
- Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
- Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
- A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
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 |
|---|---|---|
| HRS-7535(D) TabletsOne HRS-7535(D) Tablet is administered to healthy subjects. | Drug | Treatment group A, Treatment group B, Treatment group C |
| HRS-7535(C) TabletsTwo HRS-7535(C) Tablets is administered to healthy subjects. | Drug | Treatment group A, Treatment group B, Treatment group C |
Primary outcome
PK parameters：Cmax
Time frame: 0 hour to 72 hours after the last dosing
PK parameters：AUC0-t
Time frame: 0 hour to 72 hours after the last dosing
PK parameters：AUC0-∞
Time frame: 0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal
Time frame: 0 hour to 72 hours after the last dosing
Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status
Time frame: 0 hour to 72 hours after the last dosing
5 secondary outcomes
PK parameters：Tmax
Time frame: 0 hour to 72 hours after the last dosing
PK parameters： t1/2
Time frame: 0 hour to 72 hours after the last dosing
PK parameters： CL/F
Time frame: 0 hour to 72 hours after the last dosing
PK parameters： V/F
Time frame: 0 hour to 72 hours after the last dosing
Incidence and severity of adverse events (AEs)
Time frame: from screening to 72 hours after the last dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 HRS-7535(D) Tablets and HRS-7535(C) Tablets in people with Type 2 Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 29 Apr 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters：Cmax (time frame: 0 hour to 72 hours after the last dosing). The study lists 5 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 29 Apr 2026.