At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
ANG003drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating ANG003 for Exocrine Pancreatic Insufficiency. Completed, enrolled 57 participants across 20 sites.
Detailed 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 study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExocrine Pancreatic Insufficiency
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartAug 2023
First PostedSep 2023
Primary CompletionJul 2024
TodayJul 2026
First PostedSep 25, 2023
Enrollment StartAug 25, 2023
Primary CompletionJul 8, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.8 years ago
Interventions
ANG003drug
To evaluate four possible combinations of lipase, protease and amylase.