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A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects | Clinical Trials | Clareo Health

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A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects

NCT06435676•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets 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. 18-55 years of age at the time of signing informed consent.
•3. SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
•4. Subjects with good general health, no clinically significant abnormalities.

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. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
•5. Participation in other clinical trials.
•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.
+1 more criteria

Locations (1)

The Second Hospital Of Anhui medical University

Hefei, Anhui, China

Key Dates

Start Date

June 4, 2024

Primary Completion Date

October 8, 2024

Completion Date

October 8, 2024

Last Updated

May 22, 2025

Enrollment

ACTUAL participants

Conditions

Overweight or Obesity; Type 2 Diabetes

Interventions

HRS9531

DRUG

Placebo

DRUG

HRS9531

DRUG

Placebo

DRUG