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ANB033-101_Leiman - Clinical Trial

¿Cuál es el Propósito de este estudio?

This study lasts about 34 weeks. Participants will be placed into one of two groups by chance. One group will receive a study medicine called ANB033, and the other group will receive a placebo, which has no active medicine.

During the study, participants will have about 14 visits. At these visits, doctors will collect blood samples, take X rays, perform biopsies if needed, and ask participants to complete questionnaires about their health and symptoms. Researchers will use this information to learn more about the safety and effects of ANB033.

¿Cuál es la Condición que se está estudiando?

EoE, esonophilia esophagitis

¿Quién puede participar en el Estudio?

People can join this study if they are between 18 and 70 years old and have a disease called eosinophilic esophagitis, or EoE. EoE can cause swelling in the swallowing tube and make it hard to swallow solid foods. Participants must have tried a medicine called a proton pump inhibitor for at least six weeks without enough improvement, or they must not have been able to take the medicine because of side effects. They must also have a body weight level within a certain range based on BMI.

Grupo etario
Adultos

¿Qué Implica?

This study is testing a new medicine called ANB033 for people who have eosinophilic esophagitis, also called EoE. EoE is a disease that can cause swelling in the swallowing tube and make it hard to swallow food.

Researchers want to learn if ANB033 is safe and how the body absorbs, uses, and removes the medicine. The goal is to better understand how the medicine works and whether it may become a future treatment for people with EoE.

Detalles del Estudio

Título Completo
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ANB033 in Adult Participants
Investigador Principal
David A. Leiman, MD, MSHP
Especialista en gastroenterología
Número de Protocolo
IRB: PRO00121065
NCT: NA
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción
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Contribuya a Duke Health