A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 14, 2014

Primary Completion Date

May 18, 2015

Study Completion Date

May 18, 2015

Conditions
Hereditary Angioedema (HAE)
Interventions
DRUG

DX-2930

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

DRUG

Placebo

Participants will receive matching placebo subcutaneously.

Trial Locations (14)

10029

Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center, New York

11501

Winthrop-University Hospital, Clinical Trials Center, Mineola

11942

Jordan University Hospital, Amman

17033

Penn State Hershey Medical Center, Hershey

20157

Ospedale L. Sacco, Milan

20815

Institute for Asthma & Allergy, PC, Chevy Chase

33613

University of South Florida Asthma, Allergy or Immunology Clinical Research Unit, Tampa

45267

UC Physicians Company, Cincinnati

63110

Washington University School of Medicine, St Louis

75231

AARA Research Center, Dallas

92122

UC San Diego Health System - La Jolla, San Diego

94598

Allergy & Asthma Clinical Research, Walnut Creek

97035

Baker Allergy, Asthma and Dermatology Research Center, Lake Oswego

02114

Massachusetts General Hospital Allergy Associates, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT02093923 - A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants | Biotech Hunter | Biotech Hunter