Status:
COMPLETED
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Lead Sponsor:
Alvine Pharmaceuticals Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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-Contro...
Eligibility Criteria
Inclusion
- INCLUSION
- Health Status
- Healthy volunteers must be in good health
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00626184
Start Date
February 1 2008
End Date
July 1 2008
Last Update
August 18 2009
Active Locations (1)
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1
Clinical Applications Laboratories Inc.
San Diego, California, United States, 92103