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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626184
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Alvine Pharmaceuticals Inc.

Study Description
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Brief Summary:
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: 4 dose levels of ALV003 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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 Start Date : February 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: A
Placebo
 Drug: 4 dose levels of ALV003
4 dose levels of ALV003 vs placebo
Other Name: 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 Name: ALV003 and ALV003 placebo equivalent


Outcome Measures
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Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: Throughout ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626184


Locations
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United States, California
Clinical Applications Laboratories Inc.
San Diego, California, United States, 92103
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
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Principal Investigator: Vijaya Pratha, MD Clinical Applications Laboratory Inc.
More Information
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Additional Information:

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Responsible Party: Vijaya Pratha, M.D., Principal Investigator, Clinical Applications Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00626184    
Other Study ID Numbers: ALV003-0811
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009
Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac Disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases