Type 2 DiabetesPhase 1NCT06132204
Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects
A Phase 1 study testing HRS-7535 Tablets in people with Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate and compare the pharmacokinetics of HRS-7535 tablets in subjects with moderate renal insufficiency and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HRS-7535 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2023to 13 Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range from 18 to 65 years old (including both ends, subject to signing the informed consent form), both male and female;
- The subject's body weight is ≥ 50 kg, and the body mass index (BMI) is within the range of 19.0~32.0 kg/m2 (including both ends);
- From the signing of the informed consent form until 6 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan;
- Before the experiment, voluntarily sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions.
- For Moderately renal insufficiency subjects， 30 mL/min ≤ GFR<60, and the renal function status is stable. Did not use drugs for treating renal insufficiency or was determined by the researcher to be stable in taking drugs for treating renal insufficiency for more than 4 weeks.
- For Healthy subjects，90 mL/min < GFR；there was no history of chronic kidney disease during screening. Weight, age, and gender should meet the matching requirements for subjects with moderate renal insufficiency.
Who cannot join
- During screening period, glutamate alanine aminotransferase (AST) ≥ 2 × Upper limit of normal range (ULN); Glutamate aspartate aminotransferase (ALT) ≥ 2 × ULN; Total bilirubin (TBIL) ≥ 1.5 × ULN;
- Abnormal and clinically significant 12 lead electrocardiogram (ECG), or ECG QTcF>450 ms (corrected according to Fridericia's formula);
- Hepatitis B surface antigen is positive, hepatitis C antibody is positive, Treponema pallidum antibody is positive, HIV antibody is positive;
- Have a history of life-threatening diseases within 5 years (excluding basal cell skin cancer or squamous cell skin cancer);
- Previous history of medullary thyroid cancer, multiple endocrine neoplasia type 2 or family history, previous history of pancreatitis or symptomatic gallbladder disease;
- Previous clinical history of gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease and active ulcers);
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- Other clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, lung, immune, psychiatric, or cardiovascular diseases) found within the first 6 months of screening;
- Have undergone gastrointestinal surgery that can cause malabsorption before screening, or have taken drugs that have a direct impact on gastrointestinal peristalsis for a long time;
- Have used drugs that may affect glucose metabolism within the first month of screening (such as systemic steroids and non-selective drugs) β Receptor blockers, monoamine oxidase inhibitors);
- Have used glucagon like peptide peptide-1 receptor agonists within the first 3 months of screening;
- Individuals with severe allergic diseases or known or suspected allergies or allergies to any component of the study drug (including multiple drug and food allergies);
- Discontinuation of glucagon like peptide-1 receptor agonist therapy due to safety/tolerance reasons or lack of efficacy in the past;
- Have received clinical trial treatment of any drug or medical device within the first 3 months or 5 half-lives (whichever is longer) before screening, or plan to participate in clinical trials of other drugs or medical devices during the trial period;
- Screening for individuals who have consumed more than 14 units of alcohol per week within the first 6 months or who have taken alcoholic products 48 hours before administration; Or positive for alcohol breath test;
- Smoking more than 5 cigarettes per day within the first 3 months of screening or using any tobacco products 48 hours before administration;
- Exercise vigorously within 48 hours before administration;
- Those who have a history of drug abuse within the past five years or have used drugs in the three months prior to the trial; Or positive for urine drug screening;
- Donate ≥ 200 mL of blood within one month before screening; Or select trauma or surgical major surgeries who have donated blood ≥ 400 mL or lost blood ≥ 400 mL within the first 3 months;
- Inability to tolerate venous puncture blood collection or needle dizziness;
- Have special dietary requirements and cannot follow a unified diet;
- Patients with fasting blood glucose>11.1 mmol/L;
- Subjects who the researchers believe have other factors that are not suitable for participating in this experiment.
- For Moderately renal insufficiency subjects: Have a history of kidney transplantation;Urinary incontinence or oliguria (such as<400 mL/d);Within 14 days prior to administration, medication other than those used to treat renal insufficiency and other accompanying diseases has been taken that affects the experiment; After examination and inquiry, according to the judgment of the researcher, there are serious accompanying diseases that pose a serious threat to the patient's safety or affect the patient's ability to complete this study.
- For Healthy subjects: Have taken any medication that affects the experiment within 14 days before administration; Those who have clinical significance in judging abnormalities through comprehensive physical examination, vital signs, laboratory examination, X-ray chest X-ray, abdominal ultrasound examination, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Single-dose, Open-label/Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects
The study is being conducted to evaluate and compare the pharmacokinetics of HRS-7535 tablets in subjects with moderate renal insufficiency and healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS-7535 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 TabletsDrug
HRS-7535 Tablets
| Study group | Role | What they receive |
|---|---|---|
| HRS-7535 Tablets-Moderately renal insufficiency subjects | Experimental | Not described Receives: Drug: HRS-7535 Tablets |
| HRS-7535 Tablets-Healthy subjects | Experimental | Not described Receives: Drug: HRS-7535 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of HRS-7535: Cmax
Measured: 0 hour to 48 hour after administration
PK parameters of HRS-7535: AUC0-t
Measured: 0 hour to 48 hour after administration
PK parameters of HRS-7535: AUC0-inf
Measured: 0 hour to Infinity hour after administration
Secondary outcomes (5)
PK parameters of HRS-7535: Tmax
Measured: 0 hour to 48 hour after administration
PK parameters of HRS-7535: t1/2
Measured: 0 hour to 48 hour after administration
PK parameters of HRS-7535: CL/F
Measured: 0 hour to 48 hour after administration
PK parameters of HRS-7535: Vz/F
Measured: 0 hour to 48 hour after administration
Adverse events
Measured: from ICF signing date to day 7 （+3）after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start21 Dec 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06132204
- Sponsor's protocol ID
- HRS-7535-102
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label/Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT06132204
- Acronym / sponsor ID
- HRS-7535-102
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 15 Nov 2023 (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 is being conducted to evaluate and compare the pharmacokinetics of HRS-7535 tablets in subjects with moderate renal insufficiency and healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-7535 Tablets-Moderately renal insufficiency subjects | Experimental | Drug: HRS-7535 Tablets |
| HRS-7535 Tablets-Healthy subjects | Experimental | Drug: HRS-7535 Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range from 18 to 65 years old (including both ends, subject to signing the informed consent form), both male and female;
- The subject's body weight is ≥ 50 kg, and the body mass index (BMI) is within the range of 19.0~32.0 kg/m2 (including both ends);
- From the signing of the informed consent form until 6 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan;
- Before the experiment, voluntarily sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions.
- For Moderately renal insufficiency subjects， 30 mL/min ≤ GFR<60, and the renal function status is stable. Did not use drugs for treating renal insufficiency or was determined by the researcher to be stable in taking drugs for treating renal insufficiency for more than 4 weeks.
Key exclusion criteria (24 listed)
- During screening period, glutamate alanine aminotransferase (AST) ≥ 2 × Upper limit of normal range (ULN); Glutamate aspartate aminotransferase (ALT) ≥ 2 × ULN; Total bilirubin (TBIL) ≥ 1.5 × ULN;
- Abnormal and clinically significant 12 lead electrocardiogram (ECG), or ECG QTcF>450 ms (corrected according to Fridericia's formula);
- Hepatitis B surface antigen is positive, hepatitis C antibody is positive, Treponema pallidum antibody is positive, HIV antibody is positive;
- Have a history of life-threatening diseases within 5 years (excluding basal cell skin cancer or squamous cell skin cancer);
- Previous history of medullary thyroid cancer, multiple endocrine neoplasia type 2 or family history, previous history of pancreatitis or symptomatic gallbladder disease;
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 TabletsHRS-7535 Tablets | Drug | HRS-7535 Tablets-Healthy subjects, HRS-7535 Tablets-Moderately renal insufficiency subjects |
Primary outcome
PK parameters of HRS-7535: Cmax
Time frame: 0 hour to 48 hour after administration
PK parameters of HRS-7535: AUC0-t
Time frame: 0 hour to 48 hour after administration
PK parameters of HRS-7535: AUC0-inf
Time frame: 0 hour to Infinity hour after administration
5 secondary outcomes
PK parameters of HRS-7535: Tmax
Time frame: 0 hour to 48 hour after administration
PK parameters of HRS-7535: t1/2
Time frame: 0 hour to 48 hour after administration
PK parameters of HRS-7535: CL/F
Time frame: 0 hour to 48 hour after administration
PK parameters of HRS-7535: Vz/F
Time frame: 0 hour to 48 hour after administration
Adverse events
Time frame: from ICF signing date to day 7 （+3）after administration
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 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. 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 Tablets in people with Type 2 Diabetes, 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 6 inclusion and 24 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 15 Oct 2024. 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 of HRS-7535: Cmax (time frame: 0 hour to 48 hour after administration). The study lists 3 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 15 Oct 2024.