A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Hea… (NCT06186492) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
United Kingdom47 participantsStarted 2023-11-14
Plain-language 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-dose Phase 1 study is to assess the safety, tolerability, and pharmacokinetics (PK) of WVE-006 compared to placebo in healthy participants following a single dose (Period 1) and multiple doses (Period 2) of WVE-006.
This information will be used to determine doses and regimes that have the potential to be pharmacologically active in patients with Alpha-1 antitrypsin deficiency in the RestorAATion 2 study, and the maximum safe and tolerable dose that may be given to these patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 a…
What they're measuring
1
The Proportion of Participants With Adverse Events
Timeframe: Adverse events are collected from the date of consent until up to 85 days after the dose in Period 1 and up to 113 days after the first dose in Period 2.