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

Alvine Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Celiac Disease

Treatments

Drug: 4 dose levels of ALV003

Study type

Interventional

Funder types

Industry

Identifiers

NCT00626184

ALV003-0811

Details and patient eligibility

About

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

Full 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

Enrollment

28 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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