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NCT Number: NCT06506175

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • 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.
  • Abnormal and clinically significant blood pressure at screening.
  • 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.
  • Presence of any clinically significant results in examination at screening visit.
  • Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
  • Presence of - clinically significant ECG results.
  • Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
  • 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.
  • 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.

Treatment and study plan

HRS9531 tablets

Drug

HRS9531 tablets.

Primary outcomes

  1. AUCtau

    Time frame: 0-24 hours after the 10th dosing.

    Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing

Secondary outcomes

  1. Tmax

    Time frame: First dose at day 1 and post-dose at day 10.

    Time to maximum plasma concentration

  2. Cmax

    Time frame: First dose at day 1 and post-dose at day 10.

    The maximum plasma concentration

  3. t1/2

    Time frame: First dose at day 1 and post-dose at day 10.

    Terminal half-life

  4. Incidence and severity of adverse events

    Time frame: Screening period up to Day 45.

  5. Anti-HRS9531 antibody

    Time frame: Before First dose at day 1 to Day 45.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianqian Yang

CONTACT

[email protected]

+86-021-61053363

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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