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A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
Lead sponsor
Asset
HRS9531
Oral · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
72
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI ≤35•Male
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, be able and willing to provide a written informed consent.
2. 18-55 years of age at the time of signing informed consent.
3. SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
4. Subjects with good general health, no clinically significant abnormalities.
Exclusion criteria
1. Known or suspected hypersensitivity to trial product(s) or related products.
2. 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.
3. Abnormal and clinically significant blood pressure at screening.
4. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
5. Participation in other clinical trials.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Endpoints (9)
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
Time frame:35 days
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
8 endpointsSAD Stage: Number of Adverse Events
Time frame:36 days
Treatment-emergent AEs (any)
event count, event
MAD Stage: Number of Adverse Events
Time frame:63 days
Treatment-emergent AEs (any)
event count, event
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Time frame:36 days
Tmax
descriptive
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
Time frame:36 days
AUC₀–∞
concentration, descriptive
Immunogenicity qualitative
Time frame:36 days
Immunogenicity (ADA)
categorical status, event
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Time frame:63 days
Tmax
descriptive
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
Time frame:63 days
AUC₀–∞
concentration, descriptive
Immunogenicity qualitative
Time frame:63 days
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.