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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hereditary Angioedema (HAE)

In brief

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.

Key facts

Study ID

NCT02093923

Run by

Shire

People needed

38

Starts

2014-05-14

Expected to finish

2015-05-18

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age at the time of screening
• Documented diagnosis of HAE (Type I or II)
• Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months reported by the participant
• Willing and able to read, understand, and sign an informed consent form
• Females of childbearing potential must agree to be abstinent or else use acceptable forms of contraception throughout study
• Males with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception throughout study

You may not qualify if…

• Exposure to an investigational drug or device within 90 days prior to study
• History of exposure within the past 5 years to a monoclonal antibody or recombinant protein bearing an Fc domain
• Concomitant diagnosis of another form of chronic angioedema
• Use of long-term prophylaxis for HAE within 90 days prior to study
• Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study; any use of C1-INH within 7 days prior to study
• Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to study
• Exposure to androgens within 90 days prior to study
• Presence of an indwelling catheter
• Diagnosis of HIV
• Active liver disease or liver function test abnormalities
• History of substance abuse or dependence
• Pregnancy or breastfeeding
• Any condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results

Where it is running

• UC San Diego Health System - La Jolla — San Diego, California, United States
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States
• University of South Florida Asthma, Allergy or Immunology Clinical Research Unit — Tampa, Florida, United States
• Institute for Asthma & Allergy, PC — Chevy Chase, Maryland, United States
• Massachusetts General Hospital Allergy Associates — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Winthrop-University Hospital, Clinical Trials Center — Mineola, New York, United States
• Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center — New York, New York, United States
• UC Physicians Company — Cincinnati, Ohio, United States
• Baker Allergy, Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Ospedale L. Sacco — Milan, MI, Italy
• Jordan University Hospital — Amman, Jordan

Full record on ClinicalTrials.gov

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