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HyperlipidemiaPhase 1NCT06541457

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

A Phase 1 study testing HRS-7249 injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hyperlipidemia
What is being tested?
HRS-7249 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
15 Aug 2024to 30 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: 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

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
Being tested
HRS-7249 injection, Placebo
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-7249 injectionDrug

    6 subjects for HRS-7249 injection

  • PlaceboDrug

    2 subjects for placebo

Study groups in NCT06541457
Study groupRoleWhat they receive
Treatment for intravenously: dose 1ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo
Treatment for intravenously: dose 2ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo
Treatment for intravenously: dose 3ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo
Treatment for intravenously: dose 4ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo
Treatment for intravenously: dose 5 (optional)ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo
Treatment for intravenously: dose 6 (optional)ExperimentalNot described
Receives: Drug: HRS-7249 injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline up to Day 169

Secondary outcomes (17)

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

    AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration

    Measured: Baseline up to 48 hours after dosing

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

    AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Measured: Baseline up to 48 hours after dosing

  3. Pharmacokinetics (PK) parameter: Cmax for HRS-7249

    Cmax: Maximum plasma concentration

    Measured: Baseline up to 48 hours after dosing

  4. Pharmacokinetics (PK) parameter: Tmax for HRS-7249

    Tmax: Time to reach maximum plasma concentration

    Measured: Baseline up to 48 hours after dosing

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

    t1/2: Terminal half-life

    Measured: Baseline up to 48 hours after dosing

  6. Pharmacokinetics (PK) parameter: CL/F of HRS-7249 for administration subcutaneously

    CL/F: Apparent clearance

    Measured: Baseline up to 48 hours after dosing

  7. Pharmacokinetics (PK) parameter: V/F of HRS-7249 for administration subcutaneously

    V/F: Apparent volume of distribution

    Measured: Baseline up to 48 hours after dosing

  8. Pharmacodynamics (PD): TG

    Measured: Baseline up to Day 169

  9. Pharmacodynamics (PD): HDL-C

    Measured: Baseline up to Day 169

  10. Pharmacodynamics (PD): LDL-C

    Measured: Baseline up to Day 169

  11. Pharmacodynamics (PD): non-HDL-C

    Measured: Baseline up to Day 169

  12. Pharmacodynamics (PD): VLDL-C

    Measured: Baseline up to Day 169

  13. Pharmacodynamics (PD): TC

    Measured: Baseline up to Day 169

  14. Pharmacodynamics (PD): Lp(a)

    Measured: Baseline up to Day 169

  15. Pharmacodynamics (PD): ApoB

    Measured: Baseline up to Day 169

  16. Pharmacodynamics (PD): ApoA1

    Measured: Baseline up to Day 169

  17. Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects

    Measured: Baseline up to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study start15 Aug 2024
  3. Primary completion30 Jul 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06541457
Sponsor's protocol ID
HRS-7249-101
Status last verified
Sep 2025
First submitted
16 Jul 2024
Last updated
15 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-7249 injection in people with Hyperlipidemia, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: Incidence of subjects with adverse events (AEs) (time frame: Baseline up to Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06541457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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