Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052293
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-08-09
Brief Title:
Phase 1 Study to Assess Safety and Efficacy of ANG003
Sponsor:
Anagram Therapeutics Inc
Organization:
Anagram Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter Study to Assess the Safety and Efficacy of ANG003 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Status:
COMPLETED
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:
None
Brief Summary:
Randomized parallel active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency The studys overall objectives are to evaluate the safety tolerability and effect of four dose levels of ANG003
Detailed Description:
The Phase 1 study was designed to compare a 24h Baseline Substrate Absorption Challenge Test SACT period with no enzymes to a 24h ANG003 SACT period with enzymes Eligible subjects will be randomly assigned with equal allocation to one of four active dose levels of lipase protease and amylase Approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites
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?:
None
Is an FDA AA801 Violation?:
None