RecruitingPhase 1NCT07431112

A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)

Phase 1, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered AIR-001 in Adults With AATD Due to PiZZ Genotype

Sponsor

AIRNA Corporation

Enrollment

54 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

Alpha 1-Antitrypsin Deficiency

Summary

This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AIR-001 MD dose level 1, a drug called AIR-001 MD dose level 2, and others for people with alpha 1-antitrypsin deficiency. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 74 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAIR-001 SAD dose level 1

AIR-001 drug product, SC

DRUGAIR-001 SAD dose level 2

AIR-001 drug product, SC

DRUGAIR-001 SAD dose level 3

AIR-001 drug product, SC

DRUGAIR-001 SAD dose level 4

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 1

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 2

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 3

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 4

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 5

AIR-001 drug product, SC

DRUGAIR-001 MD dose level 6

AIR-001 drug product, SC

Locations(8)

Clinical Study Center

Melbourne, Australia

Clinical Study Center 1

Tbilisi, Georgia

Clinical Study Center 2

Tbilisi, Georgia

Clinical Study Center

Matosinhos Municipality, Portugal

Clinical Study Center

Barcelona, Spain

Clinical Study Center

Cambridge, United Kingdom

Clinical Study Center

London, United Kingdom

Clinical Study Center

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07431112

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