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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
6 subjects for HRS-7249 injection
2 subjects for placebo
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Safety and tolerability: Incidence of subjects with adverse events (AEs)
Time frame: Baseline up to Day 169
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
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: AUC0-∞ for HRS-7249
AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: Cmax for HRS-7249
Cmax: Maximum plasma concentration
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: Tmax for HRS-7249
Tmax: Time to reach maximum plasma concentration
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: t1/2 for HRS-7249
t1/2: Terminal half-life
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: CL/F of HRS-7249 for administration subcutaneously
CL/F: Apparent clearance
Time frame: Baseline up to 48 hours after dosing
Pharmacokinetics (PK) parameter: V/F of HRS-7249 for administration subcutaneously
V/F: Apparent volume of distribution
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Time frame: Baseline up to 48 hours after dosing
Pharmacodynamics (PD): TG
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): HDL-C
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): LDL-C
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): non-HDL-C
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): VLDL-C
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): TC
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): Lp(a)
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): ApoB
Time frame: Baseline up to Day 169
Pharmacodynamics (PD): ApoA1
Time frame: Baseline up to Day 169
Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects
Time frame: Baseline up to Day 169