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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alvine Pharmaceuticals Inc.

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