Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2023-08-25
2024-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ANG003 Dose Level 1
Single administration starting dose contains lipase, protease and amylase.
ANG003
To evaluate four possible combinations of lipase, protease and amylase.
ANG003 Dose Level 2
Single administration dose contains 2x lipase, 2x protease and 2x amylase starting dose.
ANG003
To evaluate four possible combinations of lipase, protease and amylase.
ANG003 Dose Level 3
Single administration dose contains 4x lipase, 2x protease and 2x amylase starting dose.
ANG003
To evaluate four possible combinations of lipase, protease and amylase.
ANG003 Dose Level 4
Single administration dose contains 6x lipase, 3x protease and 3x amylase starting dose.
ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Interventions
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ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride \>60 mEq/L.
3. Documented history of fecal elastase \<100 µg/g stool.
4. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
5. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.
Exclusion Criteria
2. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>5% of body weight within 1 month.
3. Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
4. CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
5. Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily.
6. Subjects unable to tolerate missing a dose of PERT.
18 Years
ALL
No
Sponsors
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Anagram Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Meghana Sathe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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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
Countries
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Other Identifiers
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ANG003-22-101
Identifier Type: -
Identifier Source: org_study_id
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