CompletedPhase 1

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

China72 participantsStarted 2024-06-04

Plain-language summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
✓. 18-55 years of age at the time of signing informed consent.
✓. 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.
✓. Subjects with good general health, no clinically significant abnormalities.

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.
✕. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
✕. Participation in other clinical trials.
✕. 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.

What they're measuring

SAD Stage: Number of Adverse Events

Timeframe: 36 days

MAD Stage: Number of Adverse Events

Timeframe: 63 days

Trial details

NCT IDNCT06435676

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

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