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

This study has been completed.
Sponsor:
Information provided by:
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00626184
First received: February 13, 2008
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Celiac Disease
Drug: 4 dose levels of ALV003
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Alvine Pharmaceuticals Inc.:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626184

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

Additional Information:
No publications provided

Responsible Party: Vijaya Pratha, M.D., Principal Investigator, Clinical Applications Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00626184     History of Changes
Other Study ID Numbers: ALV003-0811
Study First Received: February 13, 2008
Last Updated: August 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac Disease

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014