A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: DX-2930; Placebo
Intervention description: 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.; Participants will receive matching placebo subcutaneously.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HAE

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.
    

Eligibility 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