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

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

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity; Type 2 Diabetes
• Intervention / Treatment: Drug: HRS9531; Drug: HRS9531; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Stage: HRS9531; Administered po once	Drug: HRS9531; Single dose escalation of HRS9531 tablets in healthy subjects; Drug: HRS9531; Multiple dose escalation of HRS9531 tablets in healthy subjects
Placebo Comparator: SAD Stage: placebo; Administered po once	Drug: Placebo; Single dose of placebo in healthy adults; Drug: Placebo; Multiple dose of placebo in healthy adults
Experimental: MAD Stage: HRS9531; Administered po for multiple dose	Drug: HRS9531; Single dose escalation of HRS9531 tablets in healthy subjects; Drug: HRS9531; Multiple dose escalation of HRS9531 tablets in healthy subjects
Placebo Comparator: MAD Stage: placebo; Administered po for multiple dose	Drug: Placebo; Single dose of placebo in healthy adults; Drug: Placebo; Multiple dose of placebo in healthy adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SAD Stage: Number of Adverse Events	36 days
MAD Stage: Number of Adverse Events	63 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration-Time to Peak (Tmax) of HRS9531	Tmax of a single dose of HRS9531 tablets	36 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531	AUC of a single dose of HRS9531 tablets	36 days
Immunogenicity qualitative	anti-HRS9531 antibody	36 days
Plasma Concentration-Time to Peak (Tmax) of HRS9531	Tmax of multiple dose of HRS9531 tablets	63 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531	AUC of multiple dose of HRS9531 tablets	63 days
Glucose	fasting plasma glucose	35 days
Immunogenicity qualitative	anti-HRS9531 antibody	63 days

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HRS9531-T-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No