Clinical Trial

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)

Study acronym: SWIFT-SC
Recruiting Phase 3
View on ClinicalTrials.gov →
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. The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.
Protocol Amendment History 4 changes
notable Trial sites expanded: 19 -> 22 locations 2026-07-14
critical Recruitment opened 2026-06-02
notable Primary completion pushed: 2026-09-29 -> 2027-09-30 2026-06-02
minor Completion pushed: 2026-09-29 -> 2027-09-30 2026-06-02
Trial Details
NCT Number NCT07555483
Lead Sponsor Grifols Therapeutics LLC
Conditions Alpha 1 Antitrypsin Deficiency
Enrollment 40 participants
Start Date 2026-05-05
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11