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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 19, 2016

Primary Completion Date

December 5, 2016

Study Completion Date

December 5, 2016

Conditions
Hereditary Angioedema (HAE)
Interventions
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

Trial Locations (1)

33014

Clinical Pharmacology of Miami, Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY