A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05893576

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

19.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: HRS9531 Drug: HRS9531	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: R group (reference formulation group)

Drug: HRS9531

Receive a single dose of HRS9531 of original formulation.

Experimental: T group (test formulation group)

Drug: HRS9531

Receive a single dose of HRS9531 of new formulation.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central hospital affiliated to Shandong first mecical university	Jinan	Shandong	China	250014

Sponsors and Collaborators

Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Shengdi Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05893576

Other Study ID Numbers:

HRS9531-103

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 9, 2023