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

• Status: Completed
• Trial end date: 2015-05-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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