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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626184
• Other study ID #: ALV003-0811
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2008
• Last updated: August 17, 2009
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2009
• Source: Alvine Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• 4 dose levels of ALV003
4 dose levels of ALV003 vs placebo

Locations

Country	Name	City	State
United States	Clinical Applications Laboratories Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Alvine Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability		Throughout	Yes

External Links

•   Alvine Home page