Phase
Condition
Hypercholesterolemia
Elevated Triglycerides (Hypertriglyceridemia)
Hypertriglyceridemia
Treatment
HRS-7249 injection
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 orabnormality such as vital signs, physical examination and laboratory examinationhave no clinical significance;
Subjects must be willing to use a highly effective method of contraception as deemedappropriate by the investigator throughout the study and for at least 6 months afterthe last study drug administration.
Exclusion
Exclusion Criteria:
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 medicaldevices within the previous 3 months of screening or planned to be conducted duringthe study period (excluding screening failures), or those who are still within 5half-lives of the drugs before screening (whichever is longer);
Those who have experienced severe trauma or surgery within the previous 6 months, orplan to undergo surgery during the trial period; Serious infected individuals withinthe previous 3 months of screening;
Those who have used any drugs during the screening period or within 2 weeks beforethe baseline period; or those who are still in 5 half-lives of the drug at the timeof 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 gammaglutamyltransferase (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 hepatitisC 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, severeblood loss (blood loss ≥ 400 mL), or who have received a blood transfusion withinfour weeks;
Those who have received the vaccine within the previous two weeks or plan to receiveit during the trial process;
Those who started new physical exercise or made significantly changed their previousexercise activities within the previous 4 weeks, or who were unable to maintainbasic stability in exercise during the study period;
Those who have made significant adjustments to their previous diet within theprevious 4 weeks, or those whose diet cannot maintain basic stability during thestudy period;
Those who smoke an average of 5 or more cigarettes per day within the previous 4weeks;
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 andbaseline period alcohol breath test (alcohol blood test can be replaced) waspositive;
Those with a history of drug use or abuse;
Researchers, assistant researchers, research assistants, pharmacists, researchcoordinators, or other directly involved protocol implementers;
The researchers believe that subjects with any unfavorable factors to participate inthis experiment.
Study Design
Connect with a study center
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
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