drugset / Trial / NCT02107872

Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500

NCT02107872 ↗

Phase 1 Completed 55 enrolled Regeneron Pharmaceuticals
RandomizedSingle-groupQuadruple-blindTreatment

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.

Timeline

Start
2014-04
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Evinacumab Monoclonal antibody 20 mg/kg Subcutaneous
Subject Evinacumab Monoclonal antibody 150 mg Subcutaneous
Subject Evinacumab Monoclonal antibody 300 mg Subcutaneous
Subject Evinacumab Monoclonal antibody 450 mg Subcutaneous

Indications