NCT06435676CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 22 May 2025
Brief summary (registry, in English)
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 24 May 2024
- Start date
- 4 Jun 2024
- Primary completion date
- 8 Oct 2024
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06435676
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 72
- From 4 Jun 2024 to the primary completion date, 8 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
Other illness
- Known or suspected hypersensitivity to trial product(s) or related products.
- Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- 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.
Other
- Abnormal and clinically significant blood pressure at screening.
- Participation in other clinical trials.
- Presence of any clinically significant results in examination at screening visit.
- Presence of - clinically significant ECG results.
- Addiction to tobacco and alcohol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.