A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With Pi*ZZ AATD
NCT ID: NCT06405633
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2024-07-19
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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WVE-006 (Dose 1)
WVE-006
RNA editing oligonucleotide
WVE-006 (Dose 2)
WVE-006
RNA editing oligonucleotide
WVE-006 (Dose 3)
WVE-006
RNA editing oligonucleotide
Interventions
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WVE-006
RNA editing oligonucleotide
Eligibility Criteria
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Inclusion Criteria
* Genetic testing confirming Pi\*ZZ.
* Participant has been a non-smoker for at least 1 year prior to screening.
Exclusion Criteria
* Participant has a history of intolerance or any medical condition that might interfere with subcutaneous injections.
* Any ongoing or recent infections.
* Any recent or planned vaccinations during the study.
* Participant has a history of regular alcohol consumption exceeding 14 standard drinks/week.
* Unwilling to abstain from alcohol for 48 hours prior to dosing at each of the dosing visits.
* Any recent or planned major surgery during the study.
* Participant has any medical condition or social circumstance that, in the opinion of the Investigator, would make the participant unsuitable for participation in the study or for dosing on Day 1, or could interfere with the assessments of safety, pharmacodynamics, or pharmacokinetics, or completion of the study.
* Participant currently on AAT augmentation therapy, planned to be on augmentation therapy anytime during the study, or has been on augmentation therapy within 30 days prior to Screening Visit.
* Donation of blood or blood products in excess of 500 mL within 12 weeks prior to Screening Visit and/or unwilling to refrain from blood donation for the duration of the study.
* Participant has received an investigational agent within 3 months of the Screening Visit.
18 Years
70 Years
ALL
No
Sponsors
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Wave Life Sciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Caracta, MD
Role: STUDY_DIRECTOR
Wave Life Sciences
Locations
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St. Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia
Dalhousie University - Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Inspiration Research Limited
Toronto, Ontario, Canada
Turku University Hospital
Turku, , Finland
Universitaetsklinikum Aachen, AoeR
Aachen, , Germany
Waikato Hospital
Hamilton, , New Zealand
Queen Elizabeth Hospital, University Hospital Birmingham
Birmingham, , United Kingdom
Cambridge University - Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WVE-006-002
Identifier Type: -
Identifier Source: org_study_id
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