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The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

A Single-center, Single-dose, Randomized, Open-label, Single-period, Parallel Bioequivalence Study of HRS9531 Injection Solution in Multi-dose Pens and Single-dose Pens in Overweight/Obese Subjects

NCT06792955•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must provide informed consent prior to the trial, demonstrating a full understanding of the trial's content, procedures and potential adverse reactions, and willingly sign a written informed consent form. They must also be willing and capable of adhering to the trial protocol to complete the study.
•2. On the day of signing the informed consent form, the subjects must be overweight/obese males or females aged 18 to 45 years inclusive of the boundary values.
•3. From the time of signing the informed consent form until two months after the last drug administration, subjects must have no plans for conception (for both male and female subjects) and must voluntarily adopt effective contraceptive measures. They must also have no plans to donate eggs/sperm. Female subjects of reproductive potential must have a negative pregnancy test.

Exclusion Criteria

•1. Subjects with a history of primary diseases in major organs, including but not limited to the nervous system, mental system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, hematopoietic system and immune system, as judged by the investigator to be unsuitable for participation in this trial.
•2. Subjects with a history of significant gastric emptying abnormalities or factors affecting gastric emptying, or clinically significant gastrointestinal diseases, or those who have undergone gastrointestinal surgery (excluding polypectomy, appendectomy and hemorrhoidectomy).
•3. Subjects who have undergone any surgery within 6 months prior to dosing, or those planning to undergo surgical procedures during the study period.
•4. Subjects who have experienced blood loss or donated blood ≥400 mL within 3 months prior to dosing or ≥200 mL within 1 month prior to dosing, or those who have received a blood transfusion within 3 months prior to dosing.
•5. Subjects who are positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCVAb), Human Immunodeficiency Virus (HIV) antibody or Treponema pallidum-specific antibody.
•6. Subjects with a history of drug use or abuse within 1 year prior to dosing, or those with a positive drug screen.
•7. Subjects who are heavy users of alcohol and tobacco (consuming an average of ≥14 units of alcohol per week for the 6 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine; smoking ≥5 cigarettes per day on average) and who are unable to abstain as required by the protocol during the trial; those with a positive alcohol screen; those with a positive cotinine screen.
•8. Subjects who have consumed foods or beverages containing methylxanthines (such as tea, coffee, cola, chocolate, energy drinks) or alcohol, or have engaged in vigorous exercise within 72 hours prior to the first use of the trial medication.
•9. Nursing women.
•10. Subjects with a history of fainting at the sight of needles or blood, difficulty in drawing blood, or inability to tolerate venous blood collection.
+3 more criteria

Locations (1)

Central Hospital Affiliated To Shandong First Medical University

Jinan, Shandong, China

Key Dates

Start Date

February 11, 2025

Primary Completion Date

June 6, 2025

Completion Date

June 6, 2025

Last Updated

June 12, 2025

Enrollment

120

ACTUAL participants

Conditions

Overweight/Obesity

Interventions

HRS9531 injection

DRUG

HRS9531 injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

Inclusion Criteria

Exclusion Criteria

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