A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

Launched by NIELSEN FERNANDEZ-BECKER · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called HB-2121 to see if it is safe for adults when given as a single oral dose. The main goal is to find out if there are any side effects and to understand how the body processes the medicine over time. Researchers will watch participants closely for 30 days after taking HB-2121 to make sure it is safe and to learn how much of the medicine stays in the blood.

Adults aged 18 and older who are generally healthy can take part, including both people with celiac disease and those without it. For people with celiac disease, they need to have a confirmed diagnosis through a biopsy and certain lab tests. Healthy volunteers must not have celiac disease or close family members with it, and they need to be able to eat gluten without problems. During the study, participants will take one dose of HB-2121, visit the clinic four times for checkups and tests, complete two remote safety visits, and fill out a short daily questionnaire for a week about how they feel. Pregnant or breastfeeding individuals and those with certain health conditions cannot join. This study is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• General Inclusion Criteria (applies to all participants):
• • Aged 18 years and older
• • Body Mass Index (BMI) between 18 and 45 kg/m2
• • Overall good health, as determined by medical history and a physical exam
• • No use of an investigational drug in the past 12 weeks
• • Able and willing to follow study procedures and provide written informed consent
• • If of childbearing potential, participants must agree to use highly effective birth control during the study period. The same applies to male participants with partners of childbearing potential
• Additional Inclusion Criteria for Healthy Volunteers:
• • No diagnosis of celiac disease
• • No first-degree relatives (parent, sibling, child) with celiac disease
• • Able to eat gluten-containing foods without adverse effects
• • No history of autoimmune gastrointestinal disorders such as Crohn's disease, ulcerative colitis, or eosinophilic enteritis
• Additional Inclusion Criteria for Participants with Celiac Disease:
• • Biopsy-confirmed diagnosis of celiac disease
• • Positive for HLA-DQ2 or HLA-DQ8 genotype
• • Positive celiac-specific serology (tTG-IgA and DGP-IgA) (historical labs acceptable)
• • No history of eosinophilic enteritis, autoimmune gastrointestinal disorders such as Crohn's disease or inflammatory bowel disease
• Exclusion Criteria (applies to all participants):
• • Pregnant, breastfeeding, or planning to become pregnant during the study period
• • History of chemotherapy or pelvic radiation
• • History of congenital long QT syndrome or prolonged QTcF interval
• • Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease
• • Current use of immunosuppressant medications
• • Known allergy or sensitivity to any ingredients in the study drug
• • Active cancer or history of cancer