A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

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

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

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

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