Safety,Tolerability,Pharmacokinetics,and Pharmacodynamics of Single and Multiple Doses of ANB033
Research type
Research Study
Full title
A Phase I, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ANB033 in Adult Participants
IRAS ID
1013483
Contact name
Anne Severtson
Contact email
Sponsor organisation
AnaptysBio, Inc
Eudract number
2024-520409-38
ISRCTN Number
ISRCTN90323813
Research summary
This is a Phase 1 first-in-human and first-in-patient study to test the safety and tolerability of the study drug, ANB033, and to test how the drug affects the body in adults, including those with Celiac Disease (CeD) or Eosinophilic Esophagitis (EoE).
CeD is an autoimmune condition in which ingestion of gluten results in inflammation and injury of the small intestine. Patients experience diarrhoea, constipation, abdominal pain, bloating, vomiting, and weight loss. The only treatment for CeD is a strict gluten-free diet, and there is no cure for CeD.
EoE is a chronic disease of the oesophagus, where lots of white blood cells (eosinophils) build up in the oesophagus. Patients experience difficulty swallowing (dysphagia), oesophageal narrowing, and food getting stuck in the oesophagus. Current treatment options for EoE do not work for everyone.
This study tests the experimental drug ANB033. It is a monoclonal antibody, a type of protein that is designed to adjust how the immune system functions. ANB033 may help to reduce inflammation, improve intestinal and oesophageal health, and alleviate symptoms of CeD and EoE.
Participants will be men and women aged 18 to 70 years old. They will stay on the study for approximately 34 to 40 weeks. Participants get injections of ANB033 or placebo (looks like the study drug but has no active drug ingredient) and get tests to monitor how they are doing. Some of the participants with CeD receive a gluten snack to eat (called a gluten challenge) for 2 weeks.
The safety of all participants will be closely watched by study doctors. In case of any discomfort, participants will receive immediate and proper care from study doctors.REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0065
Date of REC Opinion
17 Apr 2026
REC opinion
Further Information Favourable Opinion