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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)

Trial Profile

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
Phase of Trial: Phase I/II

Latest Information Update: 18 May 2025

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At a glance

  • Drugs WVE-006 (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Adverse reactions
  • Acronyms RestorAATion; RestorAATion 2
  • Sponsors WaVe life Sciences

Most Recent Events

  • 08 May 2025 According to a WaVe life Sciences media release, completed dosing in the first two cohorts and dosing underway in second single dose cohort (400 mg) and multidosing (200 mg) ongoing in first cohort (where patients are receiving 200 mg subcutaneous doses every two weeks). The data from the complete 200 mg multidose and single dose cohorts expected in 3Q 2025 and data from complete 400 mg single dose cohort expected in the fall of 2025.
  • 04 Mar 2025 According to a WaVe life Sciences media release, In the first quarter of 2025, company initiated multi-dosing in the first cohort of RestorAATion-2, where patients are receiving 200 mg subcutaneous doses every two weeks, and initiated the second single dose cohort of RestorAATion-2 at 400 mg
  • 16 Oct 2024 According to a WaVe life Sciences media release, company expects to share multidose data in 2025.

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