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A Phase 1b/2a, open-label single ascending doses and multiple ascending doses study in participants with Pi*ZZ AATD
EU CTIS ID: 2024-511981-36-00
What this study is testing
To evaluate the safety and tolerability of WVE-006 in participants with Pi ZZ AATD
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy as determined by the Investigator, based on a medical evaluation, or has mild to moderate AATD-induced lung disease (FEV1 ≥50%) and/or stable mild AATD-induced liver disease (≤F2 (≤10 kPa)) on FibroScan.
- Genetic testing confirming Pi*ZZ.
- Participant has been a non-smoker for at least 1 year prior to screening.
You likely can't join if
- Participant has a history of multiple drug allergies or of allergic reaction to an oligonucleotide or to N-acetylgalactosamine (GalNAc).
- 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.
- 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.
See the full eligibility criteria
- Healthy as determined by the Investigator, based on a medical evaluation, or has mild to moderate AATD-induced lung disease (FEV1 ≥50%) and/or stable mild AATD-induced liver disease (≤F2 (≤10 kPa)) on FibroScan.
- Genetic testing confirming Pi*ZZ.
- Participant has been a non-smoker for at least 1 year prior to screening.
- Participant has a history of multiple drug allergies or of allergic reaction to an oligonucleotide or to N-acetylgalactosamine (GalNAc).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- New Zealand
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; New Zealand; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.