A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants with Hereditary Angioedema (The ALPHA-STAR Trial) - STAR-0215-201

Astria Therapeutics Inc.0 个研究点目标入组 53 人开始时间: 2023年6月6日最近更新: 2024年7月22日

试验速览

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•At least 18 years of age at the time of Screening., Willing and able to read, understand, and sign the IRB/IEC/REC approved informed consent form (ICF)., Documented diagnosis of HAE (Type I or II). All of the following must be met: a. Documented clinical history consistent with HAE (e.g. SC or mucosal, nonpruritic swelling episodes without accompanying urticaria); c. Age at reported onset of first angioedema symptoms 30 years of age or younger, or a family history consistent with HAE Type I or II., 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 attack.

•Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor 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: a.lanadelumab within 90 days; b.berotralstat within 21 days; c.all other prophylactic therapies, within 7 days., Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy [HRT]) within 28 days prior to Screening., Any exposure to androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

发起方

Astria Therapeutics Inc.