Phase 1 Study to Assess Safety and Efficacy of ANG003

• Status: Recruiting
• Trial end date: 2024-06-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anagram Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Male and female subjects 18 years of age or older.

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:

1. 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.

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.