A Study of STAR-0215 in Participants With Hereditary Angioedema

  • End date
    Nov 29, 2024
  • participants needed
  • sponsor
    Astria Therapeutics, Inc.
Updated on 29 July 2023


The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.


This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of STAR-0215 in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second and third cohorts will receive 2 sequential doses. This is the first trial of STAR-0215 in participants with HAE and the first evaluation of a multiple-dose regimen.

Condition Hereditary Angioedema
Treatment STAR-0215
Clinical Study IdentifierNCT05695248
SponsorAstria Therapeutics, Inc.
Last Modified on29 July 2023


Yes No Not Sure

Inclusion Criteria

Documented diagnosis of HAE (type I or II). The following must be met
Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria)
Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an
investigator based on meeting the protocol-specified definition of an HAE

Exclusion Criteria

Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria
Use of therapies prescribed for the prevention of HAE attacks prior to Screening
lanadelumab within 90 days
berotralstat within 21 days
all other prophylactic therapies, within 7 days
Any exposure to angiotensin-converting enzyme inhibitors or any estrogen containing
medications with systemic absorption (such as hormonal contraceptives or
hormone replacement therapy) within 28 days prior to Screening
Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening
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