A Relative Bioavailability Study of HRS9531 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HRS9531; Drug: HRS9531

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Central hospital affiliated to Shandong first mecical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R group (reference formulation group)	Drug: HRS9531; Receive a single dose of HRS9531 of original formulation.; Drug: HRS9531; Receive a single dose of HRS9531 of new formulation.
Experimental: T group (test formulation group)	Drug: HRS9531; Receive a single dose of HRS9531 of original formulation.; Drug: HRS9531; Receive a single dose of HRS9531 of new formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): September 4, 2023

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HRS9531-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No