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

Phase 1

Completed

• Conditions: Overweight or Obesity; Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: HRS9531

• Registration Number: NCT06435676
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-26
• Study First Posted: 2024-05-30
• Study Start: 2024-06-04
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAD Stage: placebo	Placebo	Administered po for multiple dose
SAD Stage: placebo	Placebo	Administered po once
MAD Stage: HRS9531	HRS9531	Administered po for multiple dose
SAD Stage: HRS9531	HRS9531	Administered po once

Primary Outcome Measures

Name	Time	Method
MAD Stage: Number of Adverse Events	63 days
SAD Stage: Number of Adverse Events	36 days

Secondary Outcome Measures

Name	Time	Method
Immunogenicity qualitative	63 days	anti-HRS9531 antibody
Plasma Concentration-Time to Peak (Tmax) of HRS9531	63 days	Tmax of multiple dose of HRS9531 tablets
Glucose	35 days	fasting plasma glucose
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531	63 days	AUC of multiple dose of HRS9531 tablets

Trial Locations

Locations (1)

The Second Hospital Of Anhui medical University; 🇨🇳 Hefei, Anhui, China