AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of PCSK9 inhibitor AK102. The treatment period will last 12 week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Week 12
Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0(only for part 1)
Time frame: From baseline through 12 weeks
Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol
Time frame: From baseline through 12 weeks
Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol
Time frame: From baseline through 12 weeks
Percent Change From Baseline in Serum Triglyceride (TG)
Time frame: From baseline through 12 weeks
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time frame: From baseline through 12 weeks
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)
Time frame: From baseline through 12 weeks
Percent Change From Baseline in Total Cholesterol(TC)
Time frame: From baseline through 12 weeks
Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time frame: From baseline through 12 weeks
Concentrations of AK102 in Serum
Time frame: Part 1: Day 1,Day 2, Day 4, Day 8, Day 15, Day 22, D29, D57. Part 2: Day 1, Day 29, Day 57
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From baseline through 12 weeks