← Trials/Trial dossier/NCT05152277

CompletedPhase 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

90

actual

Study population

Healthy volunteers

Key I/E criterion

BMI 19-35

Primary endpoint

Treatment-emergent AEs (any)

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 IDNCT05152277
Org study IDHRS9531-101

Timeline

Milestones

Study start2021-12-06actual
Study first posted2021-12-09actual
Primary completion2022-08-24actual
Study completion2022-08-24actual
Last update posted2022-09-19actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 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 18-55 years on the date of signing informed consent (inclusive);

3. Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 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 1 month before screening, or received blood transfusion within 2 months;

5. Allergic constitution includes severe drug allergy or history of drug allergy;

6. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) 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 (6)

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.

Coverage by outcome category

Safety / tolerability / PK
5
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glucose concentration

Time frame:Start of Treatment to end of study (approximately 9 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Number of Adverse Events

Time frame:Start of Treatment to end of study (approximately 7 weeks or 9 weeks)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the plasma concentration-time curve (AUC) of HRS9531

Time frame:Start of Treatment to end of study (approximately 7 weeks)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity qualitative

Time frame:Start of Treatment to end of study (approximately 7 weeks)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

AUC of HRS9531

Time frame:Start of Treatment to end of study (approximately 9 weeks)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity qualitative

Time frame:Start of Treatment to end of study (approximately 9 weeks)

Immunogenicity (ADA)

categorical status, 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.