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NCT07555483 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Grifols Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT07555483: Recruiting Phase 3 study, sponsored by Grifols Therapeutics.
NCT07555483 is a Phase 3 study that is actively recruiting participants, run by Grifols Therapeutics. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07555483, a Phase 3 study, is actively recruiting participants, sponsored by Grifols Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Alpha-1 15%
- OTHER Liquid Alpha1-PI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-05-05 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What NCT07555483 shows while recruiting
NCT07555483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Alpha-1 15% is the first listed.
NCT07555483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07555483 about?
NCT07555483 is a clinical study titled "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)". 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...
What is the current status of trial NCT07555483?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2026-05-05. Estimated completion is 2027-09-30.
What interventions are being tested in trial NCT07555483?
The interventions under investigation include: Alpha-1 15% (DRUG), Liquid Alpha1-PI (OTHER).
Who is sponsoring clinical trial NCT07555483?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07555483's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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