A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Public ClinicalTrials.gov record NCT07555483. 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
An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)
Study identification
- NCT ID
- NCT07555483
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Grifols Therapeutics LLC
- Industry
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- Alpha-1 15% Drug
- Liquid Alpha1-PI Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Apr 20, 2026
- Primary completion
- Sep 28, 2026
- Completion
- Sep 28, 2026
- Last update posted
- Apr 28, 2026
2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Pulmonary Associates | Phoenix | Arizona | 85032 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| UCLA | Los Angelas | California | 90095 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07555483, 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 Apr 28, 2026 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07555483 live on ClinicalTrials.gov.