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

August 17, 2009 updated by: Alvine Pharmaceuticals Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Placebo
Drug: 4 dose levels of ALV003
4 dose levels of ALV003 vs placebo
Other Names:
  • ALV003 and ALV003 placebo equivalent
Active Comparator: B
Active study Drug: ALV003
Drug: 4 dose levels of ALV003
4 dose levels of ALV003 vs placebo
Other Names:
  • ALV003 and ALV003 placebo equivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability
Time Frame: Throughout
Throughout

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvine Pharmaceuticals Inc.

Investigators

  • Principal Investigator: Vijaya Pratha, MD, Clinical Applications Laboratory Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALV003-0811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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