To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of HRS-7249 in Healthy Subjects - a Randomized, Double-blind, Dose-increasing, Placebo-controlled Phase I Clinical Trial

Fujian Shengdi Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年8月15日最近更新: 2025年9月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Fujian Shengdi Pharmaceutical Co., Ltd.
入组人数: 48
试验地点: 1
主要终点: Safety and tolerability: Incidence of subjects with adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. The study plans to conduct four to six dose groups of dose 1, dose 2, dose 3, dose4, dose5 (optional), and dose 6(optional). Eight subjects will be enrolled for each dose group, with six administered HRS-7249 injection and two administered placebo. A total of 32 to 48 healthy subjects are planned to be enrolled.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Able and willing to provide a written informed consent；
•Age ≥ 18 and ≤ 65 years old on the day of signing the informed consent ；
•0.9 mmol/L≤TG≤5.6 mmol/L；
•Male or female；
•Male subjects weigh ≥ 50 kg and < 90 kg , female subjects weigh ≥ 45kg and < 90 kg, and BMI is in the range of 19~30 kg/m2 ；(including boundary values) Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance；
•Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 6 months after the last study drug administration.

排除标准

•Those who suffer from any disease that affects drug absorption, distribution, metabolism, and excretion, or can reduce compliance determined by investigators;
•Those who suffer from any clinical diseases such as as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities;
•A clinically significant history of drug allergies or atopic allergic diseases (asthma, urticaria, eczematous dermatitis);
•Those with a history of malignant diseases;
•Those with a history of involving clinical trials of any other drugs or medical devices within the previous 3 months of screening or planned to be conducted during the study period (excluding screening failures), or those who are still within 5 half-lives of the drugs before screening (whichever is longer);
•Those who have experienced severe trauma or surgery within the previous 6 months, or plan to undergo surgery during the trial period; Serious infected individuals within the previous 3 months of screening;
•Those who have used any drugs during the screening period or within 2 weeks before the baseline period; or those who are still in 5 half-lives of the drug at the time of screening (whichever is longer);
•Serum LDL-C ≥ 4.1mmol/L;
•Platelet count<100 × 109/L;
•Creatinine≥ upper limit of normal (ULN);
•Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) ≥2×ULN, or total bilirubin ≥1.5×ULN;
•During the screening period, human immunodeficiency virus antibodies (HIV-Ab), syphilis serological tests, hepatitis B virus surface antigen (HBs-Ag), or hepatitis C virus antibodies (HCV Ab) is positive;
•Creatine kinase (CK) ≥ 3 ×ULN;
•Thyroid stimulating hormone (TSH)< limit of normal (LLN) or≥ 1.5 ×ULN;
•Glomerular filtration rate (eGFR)<60 mL/min/1.73m2;
•Urine drug screening positive;
•Those with a history of blood donation within the previous three months, severe blood loss (blood loss ≥ 400 mL), or who have received a blood transfusion within four weeks;
•Those who have received the vaccine within the previous two weeks or plan to receive it during the trial process;
•Those who started new physical exercise or made significantly changed their previous exercise activities within the previous 4 weeks, or who were unable to maintain basic stability in exercise during the study period;
•Those who have made significant adjustments to their previous diet within the previous 4 weeks, or those whose diet cannot maintain basic stability during the study period;
•Those who smoke an average of 5 or more cigarettes per day within the previous 4 weeks;
•In the four weeks before screening, women's daily alcohol intake was more than 15 g, men's more than 25 g and more than twice a week, or the screening period and baseline period alcohol breath test (alcohol blood test can be replaced) was positive;
•Those with a history of drug use or abuse;
•Researchers, assistant researchers, research assistants, pharmacists, research coordinators, or other directly involved protocol implementers;
•The researchers believe that subjects with any unfavorable factors to participate in this experiment.