A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: HRS9531

• Registration Number: NCT05893576
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study Start: 2023-05-15
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-08
• Primary Completion: 2023-09-04
• Study Completion: 2023-09-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R group (reference formulation group)	HRS9531	-
T group (test formulation group)	HRS9531	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration versus time curve (AUC) of HRS953	Start of treatment up to Day 43
Maximum Concentration (Cmax) of HRS9531	Start of Treatment up to Day 43
Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%	Start of Treatment up to Day 43

Secondary Outcome Measures

Name	Time	Method
Clearance (CL/F)	Start of Treatment up to Day 43
Time to maximum concentration (Tmax)	Start of Treatment up to Day 43
Apparent terminal half-life (t1/2)	Start of Treatment up to Day 43
Apparent volume of distribution (VzF)	Start of Treatment up to Day 43
Incidence and severity of adverse events	Screening period up to Day 43

Trial Locations

Locations (1)

Central hospital affiliated to Shandong first mecical university; 🇨🇳 Jinan, Shandong, China