Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

• Status: Completed
• Trial end date: 2007-03-06
• Target enrollment: 0
• Participant gender: All

Summary

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 9 Meters Biopharma, Inc.; Alba Therapeutics

Criteria

Inclusion Criteria:

• Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.

• Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.

• Must be on a gluten-free diet for at least the past 6 months.

Exclusion Criteria:

• Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).

• Have diabetes (Type 1 or Type 2).

• Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.

• Consuming oral corticosteroids or immune suppressants.