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

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Overweight or Obesity; Type 2 Diabetes

Treatments: Drug: HRS9531; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06435676

HRS9531-T-101

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.
11. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 4 patient groups, including a placebo group

SAD Stage: HRS9531

Experimental group

Description:

Administered po once

Treatment:

Drug: HRS9531

Drug: HRS9531

SAD Stage: placebo

Placebo Comparator group

Description:

Administered po once

Treatment:

Drug: Placebo

Drug: Placebo

MAD Stage: HRS9531

Experimental group

Description:

Administered po for multiple dose

Treatment:

Drug: HRS9531

Drug: HRS9531

MAD Stage: placebo

Placebo Comparator group

Description:

Administered po for multiple dose

Treatment:

Drug: Placebo

Drug: Placebo