A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05893576
• Other study ID #: HRS9531-103
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: September 4, 2023

Study information

• Verified date: October 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• HRS9531
Receive a single dose of HRS9531 of original formulation.
• HRS9531
Receive a single dose of HRS9531 of new formulation.

Locations

Country	Name	City	State
China	Central hospital affiliated to Shandong first mecical university	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration versus time curve (AUC) of HRS953		Start of treatment up to Day 43
Primary	Maximum Concentration (Cmax) of HRS9531		Start of Treatment up to Day 43
Primary	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	Time to maximum concentration (Tmax)		Start of Treatment up to Day 43
Secondary	Apparent terminal half-life (t1/2)		Start of Treatment up to Day 43
Secondary	Clearance (CL/F)		Start of Treatment up to Day 43
Secondary	Apparent volume of distribution (VzF)		Start of Treatment up to Day 43
Secondary	Incidence and severity of adverse events		Screening period up to Day 43