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

NCT00669825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-02-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ALV003

Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg

DRUG

Placebo

Placebo to be administered via intragastric tube

Sponsors & Collaborators

  • Alvine Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Vijaya Pratha, MD · Clinical Applications Laboratories

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00669825 on ClinicalTrials.gov