Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Single-dose Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JS002 (Recombinant Humanized Anti-PCSK9 Monoclonal Antibody) Injection in Healthy Subjects.
JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia,
randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of JS002 in healthy
subjects.
In this study, the dose ascending design includes five dose level cohorts (15 mg, 50 mg, 150
mg, 300 mg, and 450 mg) administered by subcutaneous injection, and three intravenous
administration cohorts (15 mg, 150 mg, and 450 mg). Each cohort will enroll 8 to 12 subjects
(distribution of study drug and placebo in a 3:1 ratio).
The duration of the study is 84-day per subjects.
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