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Phase 1 Study to Assess Safety and Efficacy of ANG003
Sponsor: Anagram Therapeutics, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2023-08-25
Completion Date
2024-07-08
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Locations (20)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
National Jewish Health
Denver, Colorado, United States
Norton Children's Research Institute affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States
Massachusetts General Hospital,
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Harper University Hospital / Wayne State University
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
Akron Childrens Hospital
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States