Clinical trial • Phase I • Respiratory | Rare Disease | Gastroenterology
AIR-001 for Alpha-1 antitrypsin deficiency
Phase I trial of AIR-001 for Alpha-1 antitrypsin deficiency. 26 participants.
Overview
- Trial Therapeutic Area
- Respiratory | Rare Disease | Gastroenterology
- Trial Disease
- Alpha-1 antitrypsin deficiency
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 17-12-2025
- First CTIS Authorization Date
- 17-04-2026
Trial design
Phase I trial in Germany, Ireland, Portugal and others.
- Target Sample Size
- 26
Eligibility
Recruits 26 Vulnerable population selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 26
- Recruitment Window Months
- 20
- Consent Approach
- Informed consent provided by adult participants; no further details on consent/assent process or languages provided.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 19
Germany
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Medizinische Klinik Ill
- Principal Investigator Name
- Pavel Strnad
- Principal Investigator Email
- pstrnad@ukaachen.de
- Contact Person Name
- Pavel Strnad
- Contact Person Email
- pstrnad@ukaachen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medicine
- Principal Investigator Name
- Ulrich Lauer
- Principal Investigator Email
- ulrich.lauer@uni-tuebingen.de
- Contact Person Name
- Ulrich Lauer
- Contact Person Email
- ulrich.lauer@uni-tuebingen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Pneumology
- Principal Investigator Name
- Nora Drick
- Principal Investigator Email
- Greer.Mark@mh-hannover.de
- Contact Person Name
- Nora Drick
- Contact Person Email
- Greer.Mark@mh-hannover.de
- Site Name
- Universitaet Des Saarlandes
- Department Name
- Int. Medicine and Pneumology
- Principal Investigator Name
- Robert Bals
- Principal Investigator Email
- robert.Bals@uks.eu
- Contact Person Name
- Robert Bals
- Contact Person Email
- robert.Bals@uks.eu
Ireland
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Beaumont Hospital
- Department Name
- Department of Medicine/ RCSI
- Principal Investigator Name
- Noel McElvaney
- Principal Investigator Email
- gmcelvaney@rcsi.ie
- Contact Person Name
- Noel McElvaney
- Contact Person Email
- gmcelvaney@rcsi.ie
Portugal
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 86
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Department Name
- Pneumology
- Principal Investigator Name
- Joana Amado
- Principal Investigator Email
- joana.amado@ulsm.min-saude.pt
- Contact Person Name
- Joana Amado
- Contact Person Email
- joana.amado@ulsm.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Principal Investigator Name
- Carlos Antonio Amado Diago
- Principal Investigator Email
- carlosantonio.amado@scsalud.es
- Contact Person Name
- Carlos Antonio Amado Diago
- Contact Person Email
- carlosantonio.amado@scsalud.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Respiratory
- Principal Investigator Name
- Marc Miravitlles
- Principal Investigator Email
- marcm@separ.es
- Contact Person Name
- Marc Miravitlles
- Contact Person Email
- marcm@separ.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-03-2026
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 45
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Centrum för Kliniska Cancerstudier
- Principal Investigator Name
- Maximillian Kordes
- Principal Investigator Email
- maximilian.kordes@regionstockholm.se
- Contact Person Name
- Maximillian Kordes
- Contact Person Email
- maximilian.kordes@regionstockholm.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 31-03-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Department of Pulmonology
- Principal Investigator Name
- Emily van 't Wout
- Principal Investigator Email
- e.f.a.van_t_wout@lumc.nl
- Contact Person Name
- Emily van 't Wout
- Contact Person Email
- e.f.a.van_t_wout@lumc.nl
Sponsor
Primary sponsor
- Full Name
- Airna Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AIR-001
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