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)

Astria Therapeutics, Inc0 个研究点目标入组 29 人开始时间: 2024年4月23日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•1. 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).
•2. 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.

•1. 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.
•2. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
•2.1. lanadelumab within 90 days
•2.2. berotralstat within 21 days
•2.3. all other prophylactic therapies, within 7 days
•3. 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.
•4. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

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