Clinical Trials Logo
  1. Home
  2. Alpha 1-Antitrypsin Deficiency
  3. NCT06186492

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

Alpha-1 Antitrypsin Deficiency Clinical Trial

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

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06186492
Study type Interventional
Source Wave Life Sciences Ltd.
Contact Clinical Operations
Phone 855-215-4687
Email Clinicaltrials@wavelifesci.com
Status Recruiting
Phase Phase 1
Start date November 14, 2023
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02547532 - Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT00005292 - Alpha1-antitrypsin Deficiency Registry N/A
Withdrawn NCT02900183 - Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels Phase 2
Terminated NCT02502201 - Environment Effect on Six-Minute Walk Test Performance N/A
Completed NCT01810458 - Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)
Active, not recruiting NCT04262284 - Respreeza® Self-administration and Learning Program (AmAREtTI Study)
Recruiting NCT06405633 - A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With Pi*ZZ AATD Phase 1/Phase 2
Completed NCT01054339 - Safety & Efficacy Study of rAAV1-CB-hAAT for Alpha-1 Antitrypsin Deficiency Phase 2
Completed NCT03815396 - Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency Phase 1
Completed NCT03008915 - Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency Phase 2
Completed NCT01419158 - Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Recruiting NCT00500123 - The Alpha-1 Foundation's and University of Florida's Alpha-1 Coded Testing (ACT) Study
Completed NCT05727800 - A Phase 1, First-in-human Study of VX-668 Phase 1
Active, not recruiting NCT05643495 - A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype Phase 2
Completed NCT02810327 - Alpha-1 Carrier Genomics Study
Terminated NCT02363946 - A Study of ARC-AAT in Healthy Volunteer Subjects and Patients With Alpha-1 Antitrypsin Deficiency (AATD) Phase 1
Completed NCT03804021 - Long-Term Follow-up Study of ADVM-043
Active, not recruiting NCT02014415 - Alpha-1 Antitrypsin Deficiency Adult Liver Study
Terminated NCT01241942 - Phase 2 Study of Ex-vivo Perfusion and Ventilation of Lungs to Assess Transplant Suitability N/A