Status:
COMPLETED
A Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7249 Injection in Healthy Subjects
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 dos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06541457
Start Date
August 15 2024
End Date
July 30 2025
Last Update
September 15 2025
Active Locations (1)
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1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009