A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HRS9531
* Drug: HRS9531


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; Age 18-45 years on the date of signing informed consent (inclusive); 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); Subjects with good general health, no clinically significant abnormalities. Exclusion Criteria: 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; Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period; Participants in clinical trials of any drug or medical device in the 3 months prior to screening; 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; Allergic constitution includes severe drug allergy or history of drug allergy; Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive; Breast-feeding women; The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a single-dose, parallel design trial, consisting of two parallel groups: a reference formulation group (R: original formulation) and a test formulation group (T: new formulation). Both R and T groups receive a same dose of HRS9531.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R group (reference formulation group)<br> | Drug: HRS9531<br>* Receive a single dose of HRS9531 of original formulation.<br>|
| Experimental: T group (test formulation group)<br> | Drug: HRS9531<br>* Receive a single dose of HRS9531 of new formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Clearance (CL/F) |  | 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 |