This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C to evaluate the safety, tolerance, PK, and PD.
This study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending doses (MAD) of SGB-3403 when single administered subcutaneously to healthy volunteers and multiple administered subcutaneously to subjects with elevated LDL-C. The study will be performed in 2 phases: SAD and MAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
SGB-3403 is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
The dosage of atorvastatin was determined by the investigator
Normal saline 0.9%
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Time frame: 57 days
Number of participants with abnormal laboratory tests results
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single dose to healthy volunteers
Time frame: 57 days
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Time frame: 169 days
Number of participants with abnormal laboratory tests results
To evaluate the safety and tolerability of SGB-3403 when administered subcutaneously in multiple-dose to subjects with elevated LDL-C
Time frame: 169 days
Maximum observed plasma concentration (Cmax)
To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
Time frame: 48 hours
Area under the concentration-time curve (AUC)
To characterize the pharmacokinetics of SGB-3403 in healthy volunteers and subjects with elevated LDL-C
Time frame: 48 hours
LDL-C change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on serum levels of LDL-C in healthy volunteers
Time frame: 180 days
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LDL-C change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on serum levels of LDL-C in subjects with elevated LDL-C
Time frame: 265 days
PCSK9 change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on plasma levels of proprotein convertase subtilisin/kexin type 9 in healthy volunteers
Time frame: 180 days
PCSK9 change from baseline
To evaluate the pharmacodynamic effect of SGB-3403 on plasma levels of proprotein convertase subtilisin/kexin type 9 in subjects with elevated LDL-C
Time frame: 265 days