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Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects
A Phase I Clinical Trial to Evaluate the Effects of Different Dosing Conditions, Timing and Food on the Pharmacokinetics of HRS9531 Tablets in Healthy Subjects
Lead sponsor
Asset
HRS9531
Oral · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
144
estimated
Study population
Healthy volunteers, Obesity / overweight
Key I/E criteria
•BMI 24-35•Male
Primary endpoint
•AUCtau
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. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
3. Body weight ≥50.0 kg, body mass index (BMI) of 24.0-35.0 kg/m^2 (both inclusive) at screening.
4. Weight change does not exceed 5 kg within 3 months before screening.
5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).
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. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
5. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
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. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.
12. 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 (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.
Safety / tolerability / PK
6 endpointsAUCtau
Time frame:0-24hrs after the 10th dosing
AUC₀–∞
concentration, descriptive
Tmax
Time frame:First dose at day 1 and post-dose at day 10
Tmax
descriptive
Cmax
Time frame:First dose at day 1 and post-dose at day 10
Cmax
concentration, descriptive
t1/2
Time frame:First dose at day 1 and post-dose at day 10
Half-life
descriptive
Incidence and severity of adverse events
Time frame:Screening period up to Day 45
Treatment-emergent AEs (any)
descriptive, event
Anti-HRS9531 antibody
Time frame:Before First dose at day 1 to Day 45
Immunogenicity (ADA)
descriptive
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.