Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

NCT ID: NCT06654960

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2024-12-26

Brief Summary

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: EXPERIMENTAL

HRS9531 injection

Intervention Type: DRUG

HRS9531 injection single dose.

Metformin Hydrochloride tablets

Intervention Type: DRUG

Metformin Hydrochloride tablets 500mg.

Interventions

HRS9531 injection

HRS9531 injection single dose.

Intervention Type: DRUG

Metformin Hydrochloride tablets

Metformin Hydrochloride tablets 500mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;

2. Male subjects aged 18-45 years on the date of signing informed consent (inclusive);

3. Body weight ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);

4. HbA1c<6.0%.

Exclusion Criteria

1. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;

2. Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)

3. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;

4. Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;

5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;

6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;

7. Allergic constitution includes severe drug allergy or history of drug allergy;

8. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;

9. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;

10. History of hypoglycaemia;

11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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 Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

HRS9531-106

Identifier Type: -

Identifier Source: org_study_id