Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open-label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANG003 Dose Level 1 		Single administration starting dose contains lipase, protease and amylase.
  • Drug: ANG003
    To evaluate four possible combinations of lipase, protease and amylase.
    Other names:
    • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental
ANG003 Dose Level 2 		Single administration dose contains 2x lipase, 2x protease and 2x amylase starting dose.
  • Drug: ANG003
    To evaluate four possible combinations of lipase, protease and amylase.
    Other names:
    • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental
ANG003 Dose Level 3 		Single administration dose contains 4x lipase, 2x protease and 2x amylase starting dose.
  • Drug: ANG003
    To evaluate four possible combinations of lipase, protease and amylase.
    Other names:
    • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental
ANG003 Dose Level 4 		Single administration dose contains 6x lipase, 3x protease and 3x amylase starting dose.
  • Drug: ANG003
    To evaluate four possible combinations of lipase, protease and amylase.
    Other names:
    • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.

Recruiting Locations

More Details

NCT ID
NCT06052293
Status
Completed
Sponsor
Anagram Therapeutics, Inc.

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 assigned with equal allocation to one of four active dose levels of lipase, protease and amylase. Approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.