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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014