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Phase 1 Study to Assess Safety and Efficacy of ANG003

NCT06052293 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-27

Study results available
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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.

Conditions

  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

ANG003

To evaluate four possible combinations of lipase, protease and amylase.

Sponsors & Collaborators

  • Anagram Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Meghana Sathe, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2024-07-08
Completion
2024-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052293 on ClinicalTrials.gov