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Study identifier: NCT07555483 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: Alpha 1 Antitrypsin Deficiency  ·  Sponsor: Grifols Therapeutics LLC

PhasePhase 3
Planned participants40
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Beatriz Garcia Castro  ·  +(34) 670923669  ·  beatriz.garcia@grifols.com

Lydia Martinez Garrido  ·  +(34) 670929415  ·  lydia.martinez@grifols.com

Always discuss trial participation with your own doctor first.

Locations (22)

GC2501 Study Site 106Birmingham, Alabama, United StatesNot Yet Recruiting
GC2501 Study Site 102Phoenix, Arizona, United StatesNot Yet Recruiting
GC2501 Study Site 107Scottsdale, Arizona, United StatesNot Yet Recruiting
GC2501 Study Site 100Los Angelas, California, United StatesNot Yet Recruiting
GC2501 Study Site 103Gainesville, Florida, United StatesNot Yet Recruiting
GC2501 Study Site 105Miami, Florida, United StatesNot Yet Recruiting
GC2501 Study Site 108Rochester, Minnesota, United StatesNot Yet Recruiting
GC2501 Study Site 104Cleveland, Ohio, United StatesNot Yet Recruiting
GC2501 Study Site 101Charleston, South Carolina, United StatesNot Yet Recruiting
GC2501 Study Site 109Dallas, Texas, United StatesNot Yet Recruiting
GC2501 Study Site 150Vejle, DenmarkRecruiting
GC2501 Study Site 250Freiburg im Breisgau, GermanyNot Yet Recruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07555483