drugset
drugset / Trial / NCT06052293

Phase 1 Study to Assess Safety and Efficacy of ANG003

NCT06052293 ↗

Phase 1 Completed 57 enrolled Anagram Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-25
Primary completion
2024-07-08
Completion
2024-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ANG003 Protein / enzyme biologic 20 mg Oral
Subject ANG003 Protein / enzyme biologic 25 mg Oral
Subject ANG003 Protein / enzyme biologic 40 mg Oral
Subject ANG003 Protein / enzyme biologic 50 mg Oral
Subject ANG003 Protein / enzyme biologic 75 mg Oral
Subject ANG003 Protein / enzyme biologic 80 mg Oral
Subject ANG003 Protein / enzyme biologic 120 mg Oral

Indications

exocrine pancreatic insufficiency