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CompletedPhase 1

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

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 HRS953Cmax of HRS9531Calculate 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

NCT IDNCT05893576
Org study IDHRS9531-103

Timeline

Milestones

Study start2023-05-15actual
Study first posted2023-06-08actual
Primary completion2023-09-04actual
Study completion2023-09-04actual
Last update posted2023-10-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Area Under the Concentration versus time curve (AUC) of HRS953

Time frame:Start of treatment up to Day 43

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum Concentration (Cmax) of HRS9531

Time frame:Start of Treatment up to Day 43

Cmax

concentration, descriptive

Primary/protocol endpoint

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

Secondary/protocol endpoint

Time to maximum concentration (Tmax)

Time frame:Start of Treatment up to Day 43

Tmax

descriptive

Secondary/protocol endpoint

Apparent terminal half-life (t1/2)

Time frame:Start of Treatment up to Day 43

Half-life

descriptive

Secondary/protocol endpoint

Clearance (CL/F)

Time frame:Start of Treatment up to Day 43

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (VzF)

Time frame:Start of Treatment up to Day 43

descriptive

Secondary/protocol endpoint

Incidence and severity of adverse events

Time frame:Screening period up to Day 43

Treatment-emergent AEs (any)

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.