Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526923
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Phase 12 Trial of SP-101 for the Treatment of Cystic Fibrosis CF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Ascending Dose Phase 12 Trial to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of SP-101 Via Nebulizer for the Treatment of Cystic Fibrosis CF
Status:
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:
SAAVe
Brief Summary:
This is a Phase 12 multicenter open-label single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy
Detailed Description:
This multi-center study is a first-in-human single ascending dose Phase 12 trial to evaluate the safety pharmacokinetics and pharmacodynamics of various dose levels in people with CF who are ineligible or intolerant to CFTR modulator therapy
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