Clinical trial NCT05893576: A Relative Bioavailability Study of HRS9531 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Concentration versus time curve (AUC) of HRS953
timeFrame: Start of treatment up to Day 43
measure: Maximum Concentration (Cmax) of HRS9531
timeFrame: Start of Treatment up to Day 43
measure: 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%
timeFrame: Start of Treatment up to Day 43
Secondary outcomes:
measure: Time to maximum concentration (Tmax)
timeFrame: Start of Treatment up to Day 43
measure: Apparent terminal half-life (t1/2)
timeFrame: Start of Treatment up to Day 43
measure: Clearance (CL/F)
timeFrame: Start of Treatment up to Day 43
measure: Apparent volume of distribution (VzF)
timeFrame: Start of Treatment up to Day 43
measure: Incidence and severity of adverse events
timeFrame: Screening period up to Day 43
Other outcomes:
Locations:
city: Jinan
country: China
facility: Central hospital affiliated to Shandong first mecical university
state: Shandong
Study officials:
References: