A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Nielsen Fernandez-Becker
18 participants
Aug 26, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121? * How much HB-2121 is in the blood over time? Researchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is. Participants will: * Receive one oral dose of HB-2121 * Attend 4 in-person clinic visits for checkups, lab tests, and monitoring * Complete 2 remote visits that include safety lab assessments * Fill out a short daily questionnaire for 7 days about symptoms and health status
Eligibility
Inclusion Criteria12
- 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
- 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
- Biopsy-confirmed diagnosis of celiac disease
- No history of eosinophilic enteritis, autoimmune gastrointestinal disorders such as Crohn's disease or inflammatory bowel disease
Exclusion Criteria7
- 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
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Interventions
HB-2121 taken once orally.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07063823