NCT00626184

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Alvine Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	4 dose levels of ALV003	4 dose levels of ALV003 vs placebo

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2008-02-29
• Last updated: 2009-08-18

Locations

1 site across 1 country: United States