The ALPHA-STAR Trial
Research type
Research Study
Full title
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)
IRAS ID
1007328
Contact name
Kristine Nardelli
Contact email
Sponsor organisation
Astria Therapeutics, Inc.
ISRCTN Number
ISRCTN99457796
Clinicaltrials.gov Identifier
Research summary
Astria Therapeutics, Inc. is sponsoring this research study to evaluate the safety and tolerability (how tolerable any side effects are) of the investigational drug STAR-0215, in patients with hereditary angioedema (HAE).
HAE is a rare genetic disorder that causes repeated and unpredictable attacks of swelling in the face, arms and legs, abdomen, genitals and airway. These attacks can be severe, painful, disabling and life threatening. Although there are approved medications for HAE, patients’ different responses to the approved medications often requires frequent dosing. The ultimate goal is to provide a safe and effective preventative treatment, dosed infrequently, to decrease the burden of disease and the burden of treatment for patients with HAE.
In HAE, the blood protein, plasma kallikrein has been shown to be overactive. STAR-0215 helps to block this protein and may therefore prevent attacks in patients with HAE. STAR-0215 may have a longer activity in the blood stream compared to other medicines that are currently approved for use in HAE, which may mean that it could be administered less frequently.
In this study, participants will be assigned to one of the following groups:
Group 1: a single dose of STAR-0215 via injection
Group 2: two doses of STAR-0215 via injection; an initial dose followed by another dose 84 days (about 3 months) later
Participants can take on-demand medicines if they have HAE attacks during the study.
There will be a screening period to confirm eligibility, and a treatment and follow-up period of 6 months for Group 1, 9 months for Group 2. Participants will undergo various tests and procedures such as: blood and urine tests, ECGs, vital signs and questionnaires.
About 18 participants will take part in the study globally, with approximately 5 participants from 3 sites within the UK.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0055
Date of REC Opinion
29 Sep 2023
REC opinion
Further Information Favourable Opinion