Purpose of this Study
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.
Who Can Participate?
Eligibility
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.
Age Range
18-70
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
David
Leiman
Protocol Number
PRO00121065
NCT ID
NA
Phase
I
Enrollment Status
Pending Open to Enrollment