NCT06052293

Phase 1 Study to Assess Safety and Efficacy of ANG003

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Anagram Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	ANG003	To evaluate four possible combinations of lipase, protease and amylase.

Timeline

• Start date: 2023-08-25
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2023-09-25
• Last updated: 2024-08-13

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study