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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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

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Detailed Description

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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

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Celiac Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Placebo

Group Type PLACEBO_COMPARATOR

4 dose levels of ALV003

Intervention Type DRUG

4 dose levels of ALV003 vs placebo

B

Active study Drug: ALV003

Group Type ACTIVE_COMPARATOR

4 dose levels of ALV003

Intervention Type DRUG

4 dose levels of ALV003 vs placebo

Interventions

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4 dose levels of ALV003

4 dose levels of ALV003 vs placebo

Intervention Type DRUG

Other Intervention Names

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ALV003 and ALV003 placebo equivalent

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes