Testing HRS-7249 injection for safety and effects in healthy individuals

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

This study is testing a new injection called HRS-7249 in healthy people to see if it's safe and how it works in the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06541457 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-7249 injection in healthy subjects. The study will involve four to six dose groups, with a total enrollment of 32 to 48 participants, where six will receive the injection and two will receive a placebo in each group. Participants will be closely monitored for any adverse effects and the drug's behavior in the body.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with specific triglyceride levels and within defined weight and BMI ranges.

Not a fit: Patients with significant underlying health conditions affecting drug metabolism or those outside the specified age, weight, or BMI criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for managing hyperlipidemia.

How similar studies have performed: Other studies have shown success with similar pharmacokinetic and pharmacodynamic evaluations, but this specific approach with HRS-7249 is novel.

Eligibility criteria

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 or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance；
6. 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 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 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);
6. 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;
7. 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);
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 gamma glutamyltransferase (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 hepatitis C 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, severe blood loss (blood loss ≥ 400 mL), or who have received a blood transfusion within four weeks;
18. Those who have received the vaccine within the previous two weeks or plan to receive it during the trial process;
19. 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;
20. 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;
21. Those who smoke an average of 5 or more cigarettes per day within the previous 4 weeks;
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 and baseline period alcohol breath test (alcohol blood test can be replaced) was positive;
23. Those with a history of drug use or abuse;
24. Researchers, assistant researchers, research assistants, pharmacists, research coordinators, or other directly involved protocol implementers;
25. The researchers believe that subjects with any unfavorable factors to participate in this experiment.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Chanjuan Deng

Conditions: Hyperlipidemia