A Relative Bioavailability Study of HRS9531 in Healthy Subjects

NCT05893576 | Completed Phase 1

• 1 other identifier: HRS9531-103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

R group (reference formulation group)

EXPERIMENTAL

Drug: HRS9531

T group (test formulation group)

EXPERIMENTAL

Drug: HRS9531

Interventions

HRS9531 DRUG

Receive a single dose of HRS9531 of original formulation.

R group (reference formulation group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Central hospital affiliated to Shandong first mecical university

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 8, 2023
• Study Start: May 15, 2023
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)