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

Who cannot take part

• Current use of immunosuppressant medications
• History of chemotherapy or pelvic radiation
• Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease
• Known allergy or sensitivity to any ingredients in the study drug
• Active cancer or history of cancer
• History of congenital long QT syndrome or prolonged QTcF interval
• Pregnant, breastfeeding, or planning to become pregnant during the study period

Other 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
• No history of eosinophilic enteritis, autoimmune gastrointestinal disorders such as Crohn's disease or inflammatory bowel disease