A Relative Bioavailability Study of HRS9531 in Healthy Subjects

NCT ID: NCT05893576

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-09-04

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

R group (reference formulation group)

Group Type: EXPERIMENTAL

HRS9531

Intervention Type: DRUG

Receive a single dose of HRS9531 of original formulation.

T group (test formulation group)

Group Type: EXPERIMENTAL

HRS9531

Intervention Type: DRUG

Receive a single dose of HRS9531 of new formulation.

Interventions

HRS9531

Receive a single dose of HRS9531 of original formulation.

Intervention Type: DRUG

HRS9531

Receive a single dose of HRS9531 of new formulation.

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. Age 18-45 years on the date of signing informed consent (inclusive);

3. Body weight ≥50 kg for male and 45 kg for female, body mass index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);

4. Subjects with good general health, no clinically significant abnormalities.

Exclusion Criteria

1. 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;

2. Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;

3. Participants in clinical trials of any drug or medical device in the 3 months prior to screening;

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

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

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

7. Breast-feeding women;

8. 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: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central hospital affiliated to Shandong first mecical university

Jinan, Shandong, China

Countries

China

Other Identifiers

HRS9531-103

Identifier Type: -

Identifier Source: org_study_id