drugset / Trial / NCT04169386

A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

NCT04169386

Phase 1 Completed 32 enrolled Akeso AD Pharmaceuticals Co., Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.

Timeline

Start
2018-05-23
Primary completion
2018-11-22
Completion
2018-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject AK102 Monoclonal antibody 75 mg Subcutaneous
Subject AK102 Monoclonal antibody 150 mg Subcutaneous
Subject AK102 Monoclonal antibody 300 mg Subcutaneous
Subject AK102 Monoclonal antibody 500 mg Subcutaneous

Indications