drugset / Trial / NCT03366688

Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.

NCT03366688

Phase 1 Completed 58 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupDouble-blindOther

Summary

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.

Timeline

Start
2017-11-27
Primary completion
2018-11-05
Completion
2018-11-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tafolecimab Monoclonal antibody 25 mg Subcutaneous
Comparator Tafolecimab Monoclonal antibody 75 mg Subcutaneous
Comparator Tafolecimab Monoclonal antibody 150 mg Subcutaneous
Comparator Tafolecimab Monoclonal antibody 300 mg Subcutaneous
Comparator Tafolecimab Monoclonal antibody 450 mg Subcutaneous
Comparator Tafolecimab Monoclonal antibody 600 mg Subcutaneous

Indications