A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Phase 1
Completed
- Conditions
- Celiac Disease
- Interventions
- Drug: 4 dose levels of ALV003
- Registration Number
- NCT00626184
- Lead Sponsor
- Alvine Pharmaceuticals Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A 4 dose levels of ALV003 Placebo B 4 dose levels of ALV003 Active study Drug: ALV003
- Primary Outcome Measures
Name Time Method safety and tolerability Throughout
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Applications Laboratories Inc.
🇺🇸San Diego, California, United States