Expired Study
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San Diego, California 92103


Purpose:

To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease


Study summary:

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


Criteria:

INCLUSION - Health Status 1. Healthy volunteers must be in good health 2. Celiac Disease must be well controlled and in good health - Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods. - Body Mass Index (BMI) of < 30 kg/m2, EXCLUSION - A positive urine test for alcohol or illegal drugs at screening. - The subject has received an experimental drug within 30 days of the present study. - History of substance abuse, within the last 5 years - Clinically significant abnormal lab values, as determined by the PI - Alcohol consumption of > 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration. - history of any medically significant condition considered by the PI to adversely affect participation in the trial


NCT ID:

NCT00626184


Primary Contact:

Principal Investigator
Vijaya Pratha, MD
Clinical Applications Laboratory Inc.


Backup Contact:

N/A


Location Contact:

San Diego, California 92103
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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