NCT02663687

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

A Randomized, Double-blind, Placebo-controlled, Ascending Dose, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intravenous and Subcutaneous Doses of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	Recombinant human C1 esterase inhibitor	Subjects will receive escalating doses I-IV as both IV and SC injections
DRUG	Placebo	Subjects will receive matching placebo
DRUG	SHP623	SHP623
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-02-19
• Primary completion: 2016-12-05
• Completion: 2016-12-05
• First posted: 2016-01-26
• Last updated: 2021-06-03
• Results posted: 2018-09-06

Locations

1 site across 1 country: United States