drugset / Trial / NCT03933293

A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH

NCT03933293

Phase 2 Completed 10 enrolled Akeso AD Pharmaceuticals Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2019-05-13
Primary completion
2021-03-15
Completion
2021-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject AK102 Monoclonal antibody 450 mg Subcutaneous
Background Ezetimibe Unknown