Clinical Trial: Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Two Stage, Single-Blind, Single Dose, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Contro

Brief Summary: ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy adult volunteers and in patients with well-controlled celiac disease, following a meal that contains gluten.

Detailed Summary: ALV003-0812 (the FED study) is designed to evaluate the safety and tolerability of a single dose of the study drug, ALV003, administered at one of four different dose levels, and following a test meal containing a small amount (1 gram) of gluten. ALV003 has been demonstrated to proteolyze (assist with the digestion of) various forms of gluten (gluten flour, wheat bread) in laboratory studies and in animals. Celiac disease has been estimated to affect 1% of the population of the United States, is related to gluten, and has a wide range of clinical manifestations including chronic gastrointestinal symptoms, malabsorption, and bone disease.
Sponsor: Alvine Pharmaceuticals Inc.

Current Primary Outcome: Safety and Tolerability [ Time Frame: Throughout ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alvine Pharmaceuticals Inc.

Dates:
Date Received: April 21, 2008
Date Started: March 2008
Date Completion:
Last Updated: February 17, 2010
Last Verified: February 2010