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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
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
50
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 19-26
Primary endpoints
•AUC of HRS953•Cmax of HRS9531•Calculate the ratio of bioavailability between the new formulation
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
8 endpointsArea Under the Concentration versus time curve (AUC) of HRS953
Time frame:Start of treatment up to Day 43
AUC₀–∞
concentration, descriptive
Maximum Concentration (Cmax) of HRS9531
Time frame:Start of Treatment up to Day 43
Cmax
concentration, descriptive
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%
Time frame:Start of Treatment up to Day 43
ratio, descriptive
Time to maximum concentration (Tmax)
Time frame:Start of Treatment up to Day 43
Tmax
descriptive
Apparent terminal half-life (t1/2)
Time frame:Start of Treatment up to Day 43
Half-life
descriptive
Clearance (CL/F)
Time frame:Start of Treatment up to Day 43
descriptive
Apparent volume of distribution (VzF)
Time frame:Start of Treatment up to Day 43
descriptive
Incidence and severity of adverse events
Time frame:Screening period up to Day 43
Treatment-emergent AEs (any)
descriptive, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.