Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
