Trial | NCT00626184  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    latiglutenase ...

  • Study Participants

    28
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
Study Started
Feb 29
2008
Primary Completion
May 31
2008
Study Completion
Jul 31
2008
Last Update
Aug 18
2009
Estimate

Drug 4 dose levels of ALV003

4 dose levels of ALV003 vs placebo

  • Other names: ALV003 and ALV003 placebo equivalent

A Placebo Comparator

Placebo

B Active Comparator

Active study Drug: ALV003

Criteria 

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
No Results Posted