Menu
Not yet recruiting NCT06506175

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

Phase I Interventional Weight Management Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS9531 tablets.
Who it may be relevant to
Registry conditions: Weight Management, Type 2 Diabetes. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug HRS9531 tablets
    HRS9531 tablets.

Primary outcome measures

  • AUCtau [Time frame: 0-24 hours after the 10th dosing.]
Secondary outcome measures (5)
  • Tmax [Time frame: First dose at day 1 and post-dose at day 10.]
  • Cmax [Time frame: First dose at day 1 and post-dose at day 10.]
  • t1/2 [Time frame: First dose at day 1 and post-dose at day 10.]
  • Incidence and severity of adverse events [Time frame: Screening period up to Day 45.]
  • Anti-HRS9531 antibody [Time frame: Before First dose at day 1 to Day 45.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The affiliated hospital of Qingdao University — Qingdao

Identifiers

NCT: NCT06506175 · HRS9531-T-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗