Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405633
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-03
Brief Title:
A Phase 1b2a Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants With PiZZ AATD
Sponsor:
Wave Life Sciences Ltd
Organization:
Wave Life Sciences Ltd
Study Overview
Official Title:
A Phase 1b2a Open-label Single Ascending Doses SAD and Multiple Ascending Doses MAD Research Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics in Participants With AATD PiZZ on WVE-006 RestorAATion-2
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RestorAATion-2
Brief Summary:
The purpose of this open-label study is to assess the safety tolerability pharmacodynamics and pharmacokinetics of WVE-006 in participants with alpha-1 antitrypsin deficiency AATD following Period 1 single ascending dose SAD and Period 2 multiple ascending doses MAD respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None