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Completed

NCT Number: NCT00626184

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

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

Completed

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Applications Laboratories Inc.

San Diego, California, 92103, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 dose levels of ALV003

Drug

4 dose levels of ALV003 vs placebo

Other names: ALV003 and ALV003 placebo equivalent

Primary outcomes

  1. safety and tolerability

    Time frame: Throughout

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Alvine Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 29, 2008
Registry last updated
Aug 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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