Zydus Lifesciences receives CDSCO clearance for Phase I clinical study of its novel PCSK9 inhibitor. The aim is to treat Dyslipidemia by inhibiting PCSK9, enhancing LDL-C removal from the bloodstream, and enabling once-in-6-month dosing.
PCSK9 inhibitor regulates LDL receptor levels responsible for cholesterol clearance, according to the company. High LDL-C in Dyslipidaemia patients poses a risk of cardiovascular events like heart attack and stroke.
Phase I study to assess safety and tolerability of anti-PCSK9 product in healthy human volunteers, conducted as a prospective randomised, double-blind, placebo-controlled study, as per Zydus.
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