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(6)

Clinical Study Center

Melbourne, Australia

Clinical Study Center 1

Tbilisi, Georgia

Clinical Study Center 2

Tbilisi, Georgia

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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