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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
Lead sponsor
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
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 18-55 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
Glycemic / diabetes
1 endpointGlucose 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 endpointsNumber 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
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
Immunogenicity qualitative
Time frame:Start of Treatment to end of study (approximately 7 weeks)
Immunogenicity (ADA)
categorical status, event
AUC of HRS9531
Time frame:Start of Treatment to end of study (approximately 9 weeks)
AUC₀–∞
concentration, descriptive
Immunogenicity qualitative
Time frame:Start of Treatment to end of study (approximately 9 weeks)
Immunogenicity (ADA)
categorical status, 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.