A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects

Fujian Shengdi Pharmaceutical Co., Ltd.1 site in 1 country50 target enrollmentDecember 2, 2024

ConditionsDyslipidemia

InterventionsPlacebo HRS-5632

DrugsHRS-5632 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Dyslipidemia
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Status: Completed
Last Updated: 29 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HRS-5632 Following a Single Subcutaneous Injection in Healthy Subjects

Registry

clinicaltrials.gov

Start Date

December 2, 2024

End Date

March 2, 2026

Last Updated

29 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the specific procedures of the trial, voluntarily participate in this trial, and sign an informed consent form;
•Age on the day of signing the informed consent form must be ≥18 and ≤55 years old (inclusive of boundary values);
•Male subjects must weigh ≥50 kg and female subjects must weigh ≥45 kg, with a Body Mass Index (BMI) within the range of 19 to 30 kg/m² (inclusive of boundary values);
•Female subjects with childbearing potential must agree to use effective contraception and avoid donating eggs from the time of signing the informed consent form until the end of the trial. Serum pregnancy tests within 7 days before the first dosing and during the trial must be negative, and they must not be breastfeeding; Male subjects with partners who have childbearing potential must agree to use effective contraception and avoid donating sperm from the time of signing the informed consent form until 6 months after the last administration of the trial medication;
•Vital signs, physical examinations, and laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function, sex hormones), 12-lead electrocardiogram, chest X-ray, and abdominal ultrasound must be normal or have abnormalities without clinical significance.

Exclusion Criteria

•Subjects with any clinically significant diseases or medical history in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic systems, or any other diseases or histories that could interfere with the trial results or any significant laboratory abnormalities judged by the investigator to be clinically meaningful;
•History of malignant tumors;
•Use of any prescription, over-the-counter, or traditional Chinese medicine within 14 days prior to the study drug administration, or within 7 half-lives of the drug at the time of screening;
•Participation in any clinical trial of drugs or medical devices within the last 3 months, or still within 7 half-lives of the drug at the time of screening (the longer standard shall prevail if both are met);
•Subjects who plan to take lipid-lowering or lipid-affecting drugs not part of this study during the trial;
•Elevated high-sensitivity C-reactive protein \>1.5 times the upper limit of normal, or prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT) \>1.25 times the upper limit of normal during the screening period;
•Positive results in infectious disease screening (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody);
•Abnormal 12-lead electrocardiogram with clinical significance, or electrocardiogram QT interval (QTcF) \> 450 ms in males, \> 470 ms in females;
•Blood donation or blood loss of ≥ 200 mL within the last month before dosing, or ≥ 400 mL within the last 3 months before dosing, or receipt of blood transfusion within the last 8 weeks;
•History of severe infection, severe trauma, or major surgery within the last 3 months before dosing; planning to undergo surgery during the trial and within two weeks after trial completion;

Arms & Interventions

Placebo

Intervention: Placebo

HRS-5632

Intervention: HRS-5632

Outcomes

Primary Outcomes

The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.

Time Frame: from the single dose administration (Day 1) to Day 337

Secondary Outcomes

Area under the concentration time curve (AUC) of HRS-5632(Following a single subcutaneous injection（Day1）to Day4,)
Maximum observed drug concentration (Cmax) of HRS-5632(Following a single subcutaneous injection（Day1）to Day4,)