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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 is a Phase 3 study that is actively recruiting participants, run by Grifols Therapeutics. The registered enrollment target is 40 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07555483
The ClinicalTrials.gov registry entry for NCT07555483 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alpha-1 15% is the first listed.
NCT07555483 reports 0 study locations.
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.
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