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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00626184
Other study ID # ALV003-0811
Secondary ID
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


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
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