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WVE-006 · RestorAATion-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)

Ensayo de Wave Life Sciences, Inc. en Alpha-1 Antitrypsin Deficiency (AATD) (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

47

previstos

Centros

1

Fin del objetivo primario

feb 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en nov 2023.

Qué mide

The Proportion of Participants With Adverse Events (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.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de WVE

Todos los de WVE, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06186492), actualizada en mar 2026.