Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

  • STATUS
    Recruiting
  • End date
    Sep 19, 2022
  • participants needed
    72
  • sponsor
    Pharvaris Netherlands B.V.
Updated on 22 September 2021
angioedema

Summary

This study evaluates the efficacy of orally administered PHA-022121 for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of PHA-022121 and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of PHA-022121 with placebo.

Description

In Part I of the study, patients in non-attack state receive the assigned active single dose of PHA-022121 at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with PHA-022121 or placebo (cross-over).

Details
Condition HEREDITARY ANGIOEDEMA, Hereditary Angioedema Types I and II, hereditary angioedema type i, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2
Treatment Placebo, PHA-022121
Clinical Study IdentifierNCT04618211
SponsorPharvaris Netherlands B.V.
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed and dated informed consent form
Diagnosis of HAE type I or II
Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
Reliable access and experience to use standard of care acute attack medications

Exclusion Criteria

Pregnancy or breast-feeding
Clinically significant abnormal electrocardiogram
Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
Abnormal hepatic function
Abnormal renal function
History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
History of documented severe hypersensitivity to any medicinal product
Participation in any other investigational drug study within defined period
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