A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema
Public ClinicalTrials.gov record NCT05695248. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Study identification
- NCT ID
- NCT05695248
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2023 (Actual)
- Primary completion
- Mar 13, 2025 (Actual)
- Completion
- Mar 13, 2025 (Actual)
- Last update posted
- May 8, 2026
2023 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | — |
| Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD. | Scottsdale | Arizona | 85251 | — |
| Allergy & Asthma Clinic of Northwest Arkansas | Bentonville | Arkansas | 72712 | — |
| Acuro Research, Inc. | Little Rock | Arkansas | 72205 | — |
| UC San Diego US HAEA Angioedema Center | San Diego | California | 92122 | — |
| Raffi Tachdjian MD, Inc | Santa Monica | California | 90404 | — |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | — |
| Institute for Asthma and Allergy, PC | Chevy Chase | Maryland | 20815 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Optimed Research | Columbus | Ohio | 43235 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05695248, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05695248 live on ClinicalTrials.gov.