Status:
COMPLETED
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
Lead Sponsor:
Wave Life Sciences Ltd.
Conditions:
Alpha-1 Antitrypsin Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is the first study in the RestorAATion clinical program. The purpose of this first-in human (FIH), double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple-do...
Eligibility Criteria
Inclusion
- Healthy as determined by the Investigator, based on a medical evaluation.
- Genetic testing confirming PI\*MM.
- Participant has been a non-smoker for at least 1 year prior to screening.
Exclusion
- Participant has a history of multiple drug allergies or of allergic reaction to an oligonucleotide or to N-acetylgalactosamine (GalNAc).
- 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.
- Participant has a history of caffeine consumption exceeding 8 cups of coffee/day.
- Use of prescription or non-prescription medications, including vitamin, dietary, and herbal supplements (including St John's Wort) within 7 days prior to the first dose of study treatment unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with interpretation of study assessments. Contraception and hormone replacement therapy (HRT) are permitted. If needed, over-the-counter (OTC) medications such as paracetamol/acetaminophen may be used acutely.
- Any recent or planned major surgery during the study.
- 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.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06186492
Start Date
November 14 2023
End Date
February 13 2025
Last Update
April 29 2025
Active Locations (1)
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1
Simbec-Orion Clinical Pharmacology,
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR