drugset / Trial / NCT02663687

Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

NCT02663687 ↗

Phase 1 Completed 48 enrolled Shire
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

Timeline

Start
2016-02-19
Primary completion
2016-12-05
Completion
2016-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant human C1 esterase inhibitor Protein / enzyme biologic — Intravenous

Indications