Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

NCT ID: NCT06506175

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2024-11-30

Brief Summary

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

Conditions

Overweight or Obese, Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

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

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

Treatment group G：Fed conditions

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

Treatment group H：Fasting conditions

Group Type: EXPERIMENTAL

HRS9531 tablets

Intervention Type: DRUG

HRS9531 tablets

Interventions

HRS9531 tablets

HRS9531 tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The affiliated hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Central Contacts

Qianqian Yang

Role: CONTACT

qianqian.yang.qy53@hengrui.com

+86 021-61053363

Facility Contacts

Yu Cao, Doctor

Role: primary

Caoyu1767@126.com

+86-0532-82911767

Other Identifiers

HRS9531-T-102

Identifier Type: -

Identifier Source: org_study_id