Safety Study of Larazotide Acetate to Treat Celiac Disease.

• Status: Completed
• Trial end date: 2006-01-26
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

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

Details

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

Criteria

Inclusion Criteria:

• Subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report).

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

Exclusion Criteria:

• Subject has Anti-Tissue Transglutaminase (tTG) > 10 EU as measured by serology

• Subject intermittently consumes clinically significant quantities of non-steroidal anti-inflammatory agents ("NSAIDs") and proton-pump inhibitors, within the last 3 days prior to the treatment visit.