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

NCT07431112 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Alpha 1 Antitrypsin Deficiency

Interventions

DRUG

AIR-001 SAD dose level 2

AIR-001 drug product, SC

DRUG

AIR-001 SAD dose level 3

AIR-001 drug product, SC

DRUG

AIR-001 SAD dose level 4

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 1

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 2

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 3

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 4

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 5

AIR-001 drug product, SC

DRUG

AIR-001 MD dose level 6

AIR-001 drug product, SC

DRUG

AIR-001 SAD dose level 1

AIR-001 drug product, SC

Sponsors & Collaborators

  • AIRNA Corporation

    lead INDUSTRY

Principal Investigators

  • Clinical Information · AIRNA Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2028-11-30
Completion
2029-01-31

Countries

  • Australia
  • Georgia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431112 on ClinicalTrials.gov