Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622668
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Phase 12 Study of NTLA-3001 in Adults with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 12 Multicenter Open-label Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of NTLA-3001 in Participants with Alpha-1 Antitrypsin Deficiency AATD-Associated Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AATD
Brief Summary:
This study will be conducted to evaluate the safety tolerability clinical activity pharmacokinetics and pharmacodynamics of NTLA-3001 in adults with alpha-1 antitrypsin deficiency AATD -associated lung disease
Detailed Description:
This study consists of 2 parts Phase 1 is an open-label single-arm ascending dose study to characterize the safety and activity of NTLA3001 and identify the dose for evaluation in Phase 2 Phase 2 will follow as an open-label dose expansion study to further characterize the safety and clinical activity of NTLA-3001 and provide an initial assessment of the effect of NTLA-3001 on clinical measures of pulmonary function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None