Status:
COMPLETED
Phase 1 Study to Assess Safety and Efficacy of ANG003
Lead Sponsor:
Anagram Therapeutics, Inc.
Conditions:
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. T...
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 ...
Eligibility Criteria
Inclusion
- Male and female subjects 18 years of age or older.
- 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.
- Documented history of fecal elastase \<100 µg/g stool.
- EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
- Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.
Exclusion
- Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours.
- Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>5% of body weight within 1 month.
- Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
- CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
- Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily.
- Subjects unable to tolerate missing a dose of PERT.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06052293
Start Date
August 25 2023
End Date
July 8 2024
Last Update
August 13 2024
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Norton Children's Research Institute affiliated with University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202