A Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7249 Injection in Healthy Subjects

Last updated: August 27, 2024
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hypercholesterolemia

Elevated Triglycerides (Hypertriglyceridemia)

Hypertriglyceridemia

Treatment

HRS-7249 injection

Placebo

Clinical Study ID

NCT06541457
HRS-7249-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide a written informed consent;

  2. Age ≥ 18 and ≤ 65 years old on the day of signing the informed consent ;

  3. 0.9 mmol/L≤TG≤5.6 mmol/L;

  4. Male or female;

  5. 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;

  6. 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:

  1. Those who suffer from any disease that affects drug absorption, distribution,metabolism, and excretion, or can reduce compliance determined by investigators;

  2. Those who suffer from any clinical diseases such as as cardiovascular, liver,kidney, digestive tract, psychiatric, hematological, metabolic abnormalities;

  3. A clinically significant history of drug allergies or atopic allergic diseases (asthma, urticaria, eczematous dermatitis);

  4. Those with a history of malignant diseases;

  5. 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);

  6. 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;

  7. 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);

  8. Serum LDL-C ≥ 4.1mmol/L;

  9. Platelet count<100 × 109/L;

  10. Creatinine≥ upper limit of normal (ULN);

  11. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gammaglutamyltransferase (GGT) ≥2×ULN, or total bilirubin ≥1.5×ULN;

  12. 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;

  13. Creatine kinase (CK) ≥ 3 ×ULN;

  14. Thyroid stimulating hormone (TSH)< limit of normal (LLN) or≥ 1.5 ×ULN;

  15. Glomerular filtration rate (eGFR)<60 mL/min/1.73m2;

  16. Urine drug screening positive;

  17. 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;

  18. Those who have received the vaccine within the previous two weeks or plan to receiveit during the trial process;

  19. 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;

  20. 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;

  21. Those who smoke an average of 5 or more cigarettes per day within the previous 4weeks;

  22. 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;

  23. Those with a history of drug use or abuse;

  24. Researchers, assistant researchers, research assistants, pharmacists, researchcoordinators, or other directly involved protocol implementers;

  25. The researchers believe that subjects with any unfavorable factors to participate inthis experiment.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: HRS-7249 injection
Phase: 1
Study Start date:
August 15, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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