IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Ascending dose design includes 6 dose levels (25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg). Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose. Total duration of the study per subject is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
58
Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
Peking University First Hospital
Beijing, China
Number of participants with adverse events(AEs) as assessed by the criteria of National Institute on Aging
Time frame: up to 12 weeks
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame: up to 12 weeks
Maximum concentration (Cmax) of the drug after the administration
Time frame: up to 12 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration
Time frame: up to 12 weeks
The half-life (t1/2) of drug after the administration
Time frame: up to 12 weeks
Assessment of serum concentrations of PCSK-9
Time frame: up to 12 weeks
Change from baseline in lipid parameters
Time frame: up to 12 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies
Time frame: up to 12 weeks
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