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)
NCT07555483
This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .
Summary
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein. Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Alpha 1 Antitrypsin Deficiency
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Grifols Therapeutics LLC
- Last updated on ClinicalTrials.gov
- October 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- GC2501 Study Site 106 · Birmingham, AL
Arizona · 1
- GC2501 Study Site 102 · Phoenix, AZ
South Carolina · 1
- GC2501 Study Site 101 · Charleston, SC
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.