Loading clinical trials...

Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT06506175•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, China

Key Dates

Start Date

August 5, 2024

Primary Completion Date

November 30, 2024

Completion Date

November 30, 2024

Last Updated

July 17, 2024

Enrollment

144

ESTIMATED participants

Conditions

Overweight or Obese, Type 2 Diabetes

Interventions

HRS9531 tablets

DRUG

Contacts

Qianqian Yang

CONTACT

+86 021-61053363 qianqian.yang.qy53@hengrui.com