Healthy volunteers help uncover drug interactions for future diabetes care
NCT ID NCT06727838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how two drugs, metformin and HRS-7535, behave in the bodies of 18 healthy men aged 18-50. The goal was to measure drug levels and safety, not to treat any disease. Results will help guide future diabetes research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
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Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign informed consent before the start of activities related to this experiment, be able to communicate well with the investigators, understand the procedures and methods of this experiment, and be willing to strictly follow the clinical trial protocol to complete this experiment; 2. Healthy male aged 18-50 years old (including both ends of the value, subject to the signing of the informed consent); 3. Weight ≥ 50 kg, and body mass index (BMI): 22\~26 kg/m2 (including both ends of the value); 4. Signed informed consent to have no birth plan for 6 months after the last dose, and agreed to take effective contraceptive measures. Exclusion Criteria: 1. Have a history of drug or food allergy, or are allergic; 2. Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors affecting the administration and absorption of drugs; 3. QTcF \> 450 ms was detected by 12-lead electrocardiogram during screening or there were other abnormalities that were clinically significant as determined by the investigator; 4. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, syphilis antibody test positive; 5. Those who smoked more than 5 cigarettes per day in the 3 months prior to screening and could not stop using any tobacco products during the test; 6. Regular drinkers in the 6 months prior to screening, i.e. those who drink more than 14 units of alcohol per week (1 unit = 285 mL for beer, or 25 mL for spirits, or 100 mL for wine) and cannot stop using any alcohol-containing products during the test period, who test positive for alcohol breath test; 7. Patients with a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration; 8. Patients who have received any surgery within 6 months before screening; 9. Participants who have participated in clinical trials of any drug or medical device within 3 months prior to screening (subject to receiving experimental drugs or medical device intervention); 10. Blood donation (or blood loss) and blood donation (or blood loss) ≥ 400 mL within 3 months before screening, or receiving blood transfusion; 11. Patients who had any clinically significant acute disease within 1 month before screening; 12. People who have taken any prescription, over-the-counter, Chinese herbal or health product within 14 days prior to taking the study drug, and plan to take any drug or health product other than the study drug during the trial; 13. Patients with a history of severe hypoglycemia; 14. People with a history of recurrent urinary tract infections, diabetes insipidus or/and genital fungal infections; 15. Previous history of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers); 16. Previous history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, previous history of pancreatitis or symptomatic gallbladder disease; 17. 48h before the first dose until the end of the study, subjects refused to stop drinking or eating foods with high methylxanthine content, such as coffee, tea, cola, chocolate, etc.; For 7 days prior to the first dose until the end of the study, subjects refused to discontinue any beverage or food containing grapefruit; Those who have special dietary requirements and cannot comply with a unified diet; 18. Physical examination, vital signs, laboratory examination, abdominal ultrasound, chest film and other abnormal and clinically significant examination results; 19. Persons who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the trial period; 20. Subjects with other factors deemed unsuitable for participation in the study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221700, China
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Other studies related to the condition(s) this trial covers.
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