Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

Fujian Shengdi Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Overweight or Obese, Type 2 Diabetes

Treatments: Drug: HRS9531 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06506175

HRS9531-T-102

Details and patient eligibility

About

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Enrollment: 144 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 24.0-35.0 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 8 patient groups

Treatment group A：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group B：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group C：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group D：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group E：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group F：Different fasting time、dosing conditions and timing

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group G：Fed conditions

Experimental group

Treatment:

Drug: HRS9531 tablets

Treatment group H：Fasting conditions

Experimental group

Treatment:

Drug: HRS9531 tablets