Alpha-1 Antitrypsin Deficiency (AATD)Phase 1RestorAATion-1NCT06186492

A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)

A Phase 1 study testing WVE-006 in people with Alpha-1 Antitrypsin Deficiency (AATD), run by Wave Life Sciences USA, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Alpha-1 Antitrypsin Deficiency (AATD)
What is being tested?: WVE-006
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Nov 2023to 13 Feb 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Simbec-Orion Clinical Pharmacology,
Merthyr Tydfil, Wales, CF48 4DR

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses and Multiple Doses of WVE-006 in Healthy Participants

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.

Conditions: Alpha-1 Antitrypsin Deficiency (AATD)
Being tested: WVE-006
Medical subject headings: alpha 1-Antitrypsin Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WVE-006Drug
RNA editing oligonucleotide

Study groups in NCT06186492
Study group	Role	What they receive
Single Ascending Dose (SAD): WVE-006 30 milligram (mg) or placebo	Experimental	Not described Receives: Drug: WVE-006
SAD: WVE-006 100 mg or placebo	Experimental	Not described Receives: Drug: WVE-006
SAD WVE-006 200 mg or placebo	Experimental	Not described Receives: Drug: WVE-006
SAD: WVE-006 400 mg or placebo	Experimental	Not described Receives: Drug: WVE-006
SAD: WVE-006 600 mg or placebo	Experimental	Not described Receives: Drug: WVE-006
Multiple Dose: WVE-006 600 mg Every 2 weeks (Q2W) or placebo	Experimental	Not described Receives: Drug: WVE-006

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Participants With Adverse Events
The number of participants who reported an adverse event (AE) will be summarised.
Measured: 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.

Secondary outcomes (6)

Single Ascending Dose (Period 1) - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast)
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 1 of the study.
Measured: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.
Single Ascending Dose - Maximum Concentration of WVE-006 in Plasma (Cmax)
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 1 of the study.
Measured: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 1
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study.
Measured: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 1
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study.
Measured: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 29
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study.
Measured: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 29
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study.
Measured: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 202313 Feb 2025

First posted2 Jan 2024
Study start14 Nov 2023
Primary completion13 Feb 2025
Study completion13 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alpha-1 Antitrypsin Deficiency (AATD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06186492
Sponsor's protocol ID: WVE-006-001
Acronym: RestorAATion-1
Status last verified: Mar 2026
First submitted: 9 Nov 2023
Last updated: 23 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 1
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Not yet recruitingPhase 1/2
A Study of the Safety and Efficacy of Prime Editing (PM647a) in Participants With Alpha-1 Antitrypsin Deficiency
Alpha-1 Antitrypsin Deficiency, Alpha-1 Antitrypsin Deficiency-associated Lung Disease
RecruitingPhase 1/2
A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With Pi*ZZ AATD
Alpha-1 Antitrypsin Deficiency

All Alpha-1 Antitrypsin Deficiency (AATD) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses and Multiple Doses of WVE-006 in Healthy Participants
ClinicalTrials.gov ID: NCT06186492
Acronym / sponsor ID: RestorAATion-1 / WVE-006-001
Conditions: Alpha-1 Antitrypsin Deficiency (AATD)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Wave Life Sciences USA, Inc.Industry (pharma, biotech, devices)
Study start: 14 Nov 2023 (actual)
Primary completion: 13 Feb 2025 (actual)
Study completion: 13 Feb 2025 (actual)
First posted: 2 Jan 2024 (actual)
Results: Posted 23 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is the first study in the RestorAATion clinical program.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Single Ascending Dose (SAD): WVE-006 30 milligram (mg) or placebo	Experimental	Drug: WVE-006
SAD: WVE-006 100 mg or placebo	Experimental	Drug: WVE-006
SAD WVE-006 200 mg or placebo	Experimental	Drug: WVE-006
SAD: WVE-006 400 mg or placebo	Experimental	Drug: WVE-006
SAD: WVE-006 600 mg or placebo	Experimental	Drug: WVE-006
Multiple Dose: WVE-006 600 mg Every 2 weeks (Q2W) or placebo	Experimental	Drug: WVE-006

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WVE-006RNA editing oligonucleotide	Drug	Multiple Dose: WVE-006 600 mg Every 2 weeks (Q2W) or placebo, SAD WVE-006 200 mg or placebo, SAD: WVE-006 100 mg or placebo, SAD: WVE-006 400 mg or placebo, SAD: WVE-006 600 mg or placebo, Single Ascending Dose (SAD): WVE-006 30 milligram (mg) or placebo

Primary outcome

The Proportion of Participants With Adverse Events
Time frame: 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.
The number of participants who reported an adverse event (AE) will be summarised.

6 secondary outcomes

Single Ascending Dose (Period 1) - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast)
Time frame: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.
Single Ascending Dose - Maximum Concentration of WVE-006 in Plasma (Cmax)
Time frame: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 1
Time frame: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 1
Time frame: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 29
Time frame: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 29
Time frame: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.

Results and safety

Results posted to the registry on 23 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1: Pooled Placebo	10	10
Period 1 Cohort 1 - WVE-006 30 mg	6	6
Period 1 Cohort 2 - WVE-006 100 mg	5	5
Period 1 Cohort 3 - WVE-006 200 mg	6	6
Period 1 Cohort 4 - WVE-006 400 mg	6	6
Period 1 Cohort 5 - WVE-006 600 mg	6	5
Period 2 Cohort 1 - WVE-006 600 mg Q2W	6	6
Period 2 Cohort 1 - Placebo Q2W	2	2

Primary outcome: The Proportion of Participants With Adverse Events

Time frame: 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.. Count of participants. Unit: Participants

Measure	Period 1: Pooled Placebo n = 10	Period 1 Cohort 1 - WVE-006 30 mg n = 6	Period 1 Cohort 2 - WVE-006 100 mg n = 5	Period 1 Cohort 3 - WVE-006 200 mg n = 6	Period 1 Cohort 4 - WVE-006 400 mg n = 6	Period 1 Cohort 5 - WVE-006 600 mg n = 6	Period 2 Cohort 1 - WVE-006 600 mg Q2W n = 6	Period 2 Cohort 1 - Placebo Q2W n = 2
Value	8	5	4	3	3	3	2	1

Population analysed: This analysis population included 47 enrolled participants who received at least one dose of WVE-006 or matching placebo.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: Pooled Placebo	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Period 1 Cohort 1 - WVE-006 30 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Period 1 Cohort 2 - WVE-006 100 mg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Period 1 Cohort 3 - WVE-006 200 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Period 1 Cohort 4 - WVE-006 400 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Period 1 Cohort 5 - WVE-006 600 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Period 2 Cohort 1 - WVE-006 600 mg Q2W	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Period 2 Cohort 1 - Placebo Q2W	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Alpha-1 Antitrypsin Deficiency (AATD)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia Caracta, MD study director

Wave Life Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WVE-006 in people with Alpha-1 Antitrypsin Deficiency (AATD), run by Wave Life Sciences USA, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Participants With Adverse Events (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06186492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.