Type 2 Diabetes, Weight Management
Conditions
Brief summary
The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.
Interventions
DRUGHRS9531 tablets
HRS9531 tablets.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand the trial procedures, be able and willing to provide a written informed consent. 2. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent. 3. Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m\^2 (both inclusive) at screening. 4. Weight change does not exceed 5 kg within 3 months before screening. 5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).
Exclusion criteria
1. Known or suspected hypersensitivity to trial product(s) or related products. 2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study. 3. Abnormal and clinically significant blood pressure at screening. 4. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization. 5. Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening. 6. Presence of any clinically significant results in examination at screening visit. 7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive. 8. Presence of - clinically significant ECG results. 9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive. 10. Addiction to tobacco and alcohol. 11. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period. 12. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau | 0-24 hours after the 10th dosing. | Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | First dose at day 1 and post-dose at day 10. | Time to maximum plasma concentration |
| Cmax | First dose at day 1 and post-dose at day 10. | The maximum plasma concentration |
| t1/2 | First dose at day 1 and post-dose at day 10. | Terminal half-life |
| Incidence and severity of adverse events | Screening period up to Day 45. | — |
| Anti-HRS9531 antibody | Before First dose at day 1 to Day 45. | — |
Countries
China
Contacts
CONTACTQianqian Yang
Outcome results
None listed