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

NCT06541457 | Completed Phase 1

• 1 other identifier: HRS-7249-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability: Incidence of subjects with adverse events (AEs)

  Baseline up to Day 169

Secondary Outcomes (17)

• Pharmacokinetics (PK) parameter: AUC0-t for HRS-7249

  Baseline up to 48 hours after dosing

• Pharmacokinetics (PK) parameter: AUC0-∞ for HRS-7249

  Baseline up to 48 hours after dosing

• Pharmacokinetics (PK) parameter: Cmax for HRS-7249

  Baseline up to 48 hours after dosing

• Pharmacokinetics (PK) parameter: Tmax for HRS-7249

  Baseline up to 48 hours after dosing

• Pharmacokinetics (PK) parameter: t1/2 for HRS-7249

  Baseline up to 48 hours after dosing

Study Arms (6)

Treatment for intravenously: dose 1

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Treatment for intravenously: dose 2

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Treatment for intravenously: dose 3

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Treatment for intravenously: dose 4

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Treatment for intravenously: dose 5 (optional)

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Treatment for intravenously: dose 6 (optional)

EXPERIMENTAL

Drug: HRS-7249 injection; Drug: Placebo

Interventions

HRS-7249 injection DRUG

6 subjects for HRS-7249 injection

Treatment for intravenously: dose 1; Treatment for intravenously: dose 2; Treatment for intravenously: dose 3; Treatment for intravenously: dose 4; Treatment for intravenously: dose 5 (optional); Treatment for intravenously: dose 6 (optional)

Placebo DRUG

2 subjects for placebo

Treatment for intravenously: dose 1; Treatment for intravenously: dose 2; Treatment for intravenously: dose 3; Treatment for intravenously: dose 4; Treatment for intravenously: dose 5 (optional); Treatment for intravenously: dose 6 (optional)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent；
• Age ≥ 18 and ≤ 65 years old on the day of signing the informed consent ；
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 7, 2024
• Study Start: August 15, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CN (1)