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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for intravenously: dose 1 | Experimental |
| |
| Treatment for intravenously: dose 2 | Experimental |
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| Treatment for intravenously: dose 3 | Experimental |
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| Treatment for intravenously: dose 4 | Experimental |
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| Treatment for intravenously: dose 5 (optional) | Experimental |
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| Treatment for intravenously: dose 6 (optional) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7249 injection | Drug | 6 subjects for HRS-7249 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Incidence of subjects with adverse events (AEs) | Baseline up to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: AUC0-∞ for HRS-7249 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | 2 subjects for placebo |
|
AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity |
| Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: Cmax for HRS-7249 | Cmax: Maximum plasma concentration | Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: Tmax for HRS-7249 | Tmax: Time to reach maximum plasma concentration | Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: t1/2 for HRS-7249 | t1/2: Terminal half-life | Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: CL/F of HRS-7249 for administration subcutaneously | CL/F: Apparent clearance | Baseline up to 48 hours after dosing |
| Pharmacokinetics (PK) parameter: V/F of HRS-7249 for administration subcutaneously | V/F: Apparent volume of distribution | Baseline up to 48 hours after dosing |
| Pharmacodynamics (PD): TG | Baseline up to Day 169 |
| Pharmacodynamics (PD): HDL-C | Baseline up to Day 169 |
| Pharmacodynamics (PD): LDL-C | Baseline up to Day 169 |
| Pharmacodynamics (PD): non-HDL-C | Baseline up to Day 169 |
| Pharmacodynamics (PD): VLDL-C | Baseline up to Day 169 |
| Pharmacodynamics (PD): TC | Baseline up to Day 169 |
| Pharmacodynamics (PD): Lp(a) | Baseline up to Day 169 |
| Pharmacodynamics (PD): ApoB | Baseline up to Day 169 |
| Pharmacodynamics (PD): ApoA1 | Baseline up to Day 169 |
| Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects | Baseline up to Day 169 |