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A Phase 1b/2a Open-label Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) Research Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Participants with AATD Pi*ZZ on WVE-006 (RestorAATion-2)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511981-36-00
Acronym
WVE-006-002
Enrollment
7
Registered
2024-12-03
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha-1 antitrypsin deficiency (AATD)

Brief summary

The proportion of participants with adverse events.

Detailed description

Single Ascending Dose - Change from baseline in levels of serum M-AAT protein., Multiple Ascending Dose - Change from baseline in levels of serum M-AAT protein, Single Ascending Dose - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast), Single Ascending Dose - Maximum concentration of WVE-006 in plasma, Multiple Ascending Doses - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast), Multiple Ascending Doses - Maximum concentration of WVE-006 in plasma (Cmax)

Interventions

Sponsors

Wave Life Sciences Ireland Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of participants with adverse events.

Secondary

MeasureTime frame
Single Ascending Dose - Change from baseline in levels of serum M-AAT protein., Multiple Ascending Dose - Change from baseline in levels of serum M-AAT protein, Single Ascending Dose - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast), Single Ascending Dose - Maximum concentration of WVE-006 in plasma, Multiple Ascending Doses - Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast), Multiple Ascending Doses - Maximum concentration of WVE-006 in plasma (Cmax)

Countries

Finland, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026