NCT00626184

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

3 months

First QC Date

February 13, 2008

Last Update Submit

August 17, 2009

Conditions

Celiac Disease

Keywords

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability

    Throughout

Study Arms (2)

A

PLACEBO COMPARATOR

Placebo

Drug: 4 dose levels of ALV003

B

ACTIVE COMPARATOR

Active study Drug: ALV003

Drug: 4 dose levels of ALV003

Interventions

4 dose levels of ALV003DRUG

4 dose levels of ALV003 vs placebo

Also known as: ALV003 and ALV003 placebo equivalent
AB

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Applications Laboratories Inc.

San Diego, California, 92103, United States

Location

Related Links

MeSH Terms

Conditions

Celiac Disease

Interventions

ALV003

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Vijaya Pratha, MD

    Clinical Applications Laboratory Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

US(1)