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NCT06506175Not yet recruitingPhase 1

A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Source: ClinicalTrials.gov · Last updated 24 Jun 2026

Brief summary (registry, in English)

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
100 (estimated)
First submitted
11 Jul 2024
Start date
Jul 2026
Primary completion date
Sept 2026
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
NCT number
NCT06506175

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 100
  • From Jul 2026 to the primary completion date, Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening.

Other illness

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
  • Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
  • 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.

Other

  • Abnormal and clinically significant blood pressure at screening.
  • Presence of any clinically significant results in examination at screening visit.
  • Presence of - clinically significant ECG results.
  • Addiction to tobacco and alcohol.
  • 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.

Who the study is looking for

  • Ability to understand the trial procedures, be able and willing to provide a written informed consent.
  • Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m\^2 (both inclusive) at screening.
  • Weight change does not exceed 5 kg within 3 months before screening.
  • Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).

Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Affiliated Hospital of Qingdao University
Coordinator of this site? Confirm its status
QingdaoChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.