Safety Study of AT1001 to Treat Celiac Disease.

2014-08-27 03:42:08 | BioPortfolio


To demonstrate the safety and tolerance of single, oral doses of AT-1001 in celiac disease subjects that are gluten-free diets and in remission.


One (1) cohort of 24 (2:1 drug:placebo) subjects will receive single oral doses of either AT-1001 or matching placebo. Subjects will complete screening and thereafter be admitted to the clinic prior to treatment. On Day 1 AT-1001 or matching placebo will be administered followed by a baseline intestinal permeability test. Intestinal permeability will be measured by administration of an oral sucrose, lactulose and mannitol solution followed by an 8-hour urine collection. Day 2 subjects will be given AT-1001 or matching placebo followed by a gluten challenge and have the intestinal permeability test repeated. Day 3 subjects will be administered AT-1001 or matching placebo followed by a post gluten challenge intestinal permeability test. Serial blood samples will be collected for pharmacokinetic determinations at baseline, 2, and 3 hours post administration of AT-1001 or matching placebo, for zonulin determinations at baseline (prior to first dose) and at 3 hours post dose, and for cytokine determination at baseline, 3 hours post dose (Days 2 and 3 only) and Day 7. Sucrose, lactulose, mannitol, zonulin and AT-1001 concentrations will be determined by validated analytical methods.

Subjects will be evaluated at screening (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiogram). Vital signs and clinical laboratory testing will be conducted pre-dose and vital signs, clinical laboratory testing and EKG will be monitored post dose. Adverse event reports will be monitored throughout the study. At the end of the study a physical exam and clinical laboratory testing will be performed.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Celiac Disease




United States




Alba Therapeutics

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:42:08-0400

Clinical Trials [143 Associated Clinical Trials listed on BioPortfolio]

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate (AT-1001) in Active Celiac Disease

The purpose of this research study is to look at how effective and safe larazotide acetate (AT-1001) is when it is given to subjects who have active Celiac Disease. A "leaky gut" is often...

Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease

This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of celiac disease. The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of ...

A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors

The primary objective of this study is to determine how much XMT-1001 can safely be taken by patients with advanced solid cancerous tumors (the Maximum Tolerated Dose). The study will als...

Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?

This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic an...

Evidence-based Screening Strategies for Celiac Disease

Main aim: To find evidence-based screening strategies for celiac disease in high risk groups and to find new biomarkers or biomarker combinations for celiac disease diagnostics and follow-...

PubMed Articles [14375 Associated PubMed Articles listed on BioPortfolio]

Synthetic Neoepitopes of the Transglutaminase-Deamidated Gliadin Complex as Biomarkers for Diagnosing and Monitoring Celiac Disease.

Celiac disease has characteristics of an autoimmune disease, such as increased antibody levels to tissue transglutaminase (tTG). However, assays to measure these biomarkers in blood samples do not ide...

Low Sensitivity of Simtomax Point of Care Test in Detection of Celiac Disease in a Prospective Multicenter Study.

Point of care tests (POCTs) might be used to identify patients with undiagnosed celiac disease who require further evaluation. We performed a large multicenter study to determine the performance of a ...

Celiac disease and endocrine autoimmunity - the genetic link.

Celiac disease is a small intestinal inflammatory disease with autoimmune features that is triggered and maintained by the ingestion of the storage proteins (gluten) of wheat, barley and rye. The prev...

Celiac Disease and Wheat Allergy: A Growing Association?

Celiac disease and wheat allergy (WA) are infrequent diseases in the general population, and a combination of the 2 is particularly rare. Celiac disease occurs in around 1% of the general population a...

In situ Gluten-Chitosan Interlocked Self-Assembled Supramolecular Architecture Reduces T-Cell-Mediated Immune Response to Gluten in Celiac Disease.

The prevalence of celiac disease has increased since the last half of the 20th century and is now about 1% in most western populations. At present, people who suffer from celiac disease have to follow...

Medical and Biotech [MESH] Definitions

A complex network of nerve fibers including sympathetic and parasympathetic efferents and visceral afferents. The celiac plexus is the largest of the autonomic plexuses and is located in the abdomen surrounding the celiac and superior mesenteric arteries.

Simple protein, one of the prolamines, derived from the gluten of wheat, rye, etc. May be separated into 4 discrete electrophoretic fractions. It is the toxic factor associated with CELIAC DISEASE.

Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is in linkage disequilibrium with HLA-A1 and HLA-B8. The HLA-DR3 antigen is strongly associated with celiac disease, Grave's disease, dermatitis herpetiformis, early-age onset myasthenia gravis, systemic lupus erythematosus, juvenile diabetes, and opportunistic infections in AIDS.

Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is strongly associated with celiac disease and psoriasis vulgaris.

A malabsorption syndrome that is precipitated by the ingestion of GLUTEN-containing foods, such as wheat, rye, and barley. It is characterized by INFLAMMATION of the SMALL INTESTINE, loss of MICROVILLI structure, failed INTESTINAL ABSORPTION, and MALNUTRITION.

More From BioPortfolio on "Safety Study of AT1001 to Treat Celiac Disease."

Quick Search


Relevant Topics

Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Searches Linking to this Trial