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Completed

NCT Number: NCT06435676

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

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

The Second Hospital Of Anhui medical University

Hefei, Anhui, 230601, China

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.
  • 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.
  • 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.
  • 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

Drug

Single dose escalation of HRS9531 tablets in healthy subjects

Placebo

Drug

Single dose of placebo in healthy adults

Primary outcomes

  1. SAD Stage: Number of Adverse Events

    Time frame: 36 days

  2. MAD Stage: Number of Adverse Events

    Time frame: 63 days

Secondary outcomes

  1. Plasma Concentration-Time to Peak (Tmax) of HRS9531

    Time frame: 36 days

    Tmax of a single dose of HRS9531 tablets

  2. Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

    Time frame: 36 days

    AUC of a single dose of HRS9531 tablets

  3. Immunogenicity qualitative

    Time frame: 36 days

    anti-HRS9531 antibody

  4. Plasma Concentration-Time to Peak (Tmax) of HRS9531

    Time frame: 63 days

    Tmax of multiple dose of HRS9531 tablets

  5. Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

    Time frame: 63 days

    AUC of multiple dose of HRS9531 tablets

  6. Glucose

    Time frame: 35 days

    fasting plasma glucose

  7. Immunogenicity qualitative

    Time frame: 63 days

    anti-HRS9531 antibody

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
May 22, 2025

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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