Back to resultsA Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Primary Purpose
Celiac Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
4 dose levels of ALV003
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease focused on measuring Celiac Disease
Eligibility Criteria
INCLUSION
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,
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
Sites / Locations
- Clinical Applications Laboratories Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
Placebo
Active study Drug: ALV003
Outcomes
Primary Outcome Measures
safety and tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT00626184
First Posted
February 13, 2008
Last Updated
August 17, 2009
Sponsor
Alvine Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00626184
Brief Title
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
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 Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alvine Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
B
Arm Type
Active Comparator
Arm Description
Active study Drug: ALV003
Intervention Type
Drug
Intervention Name(s)
4 dose levels of ALV003
Other Intervention Name(s)
ALV003 and ALV003 placebo equivalent
Intervention Description
4 dose levels of ALV003 vs placebo
Primary Outcome Measure Information:
Title
safety and tolerability
Time Frame
Throughout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION
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,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijaya Pratha, MD
Organizational Affiliation
Clinical Applications Laboratory Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Applications Laboratories Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
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