Celiac Disease
Conditions
Keywords
Celiac Disease
Brief summary
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
Detailed description
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
Interventions
4 dose levels of ALV003 vs placebo
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability | Throughout |
Countries
United States