A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
1 other identifier
interventional
20
1 country
1
Brief Summary
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are:
- What side effects do participants have after receiving HB-2121?
- How does the drug interact with the small intestine in people with suspected celiac disease? 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 four hours before their standard-of-care esophagogastroduodenoscopy
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2026
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 20, 2026
July 1, 2025
1.2 years
January 9, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and severity of adverse events during the study window
Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
From dosing through 30 days post-dose
Secondary Outcomes (2)
Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view.
240 minutes after dosing
Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count.
240 minutes after dosing
Other Outcomes (2)
Frequency and identity of HB-2121 positive cells in the blood of celiac patients
Pre-dose and at 360 minutes after dosing
Intensity of of HB-2121-labeled ECM-associated and cellular TG2 protein in duodenal biopsy samples.
240 minutes after dosing
Study Arms (1)
250 mg HB-2121 in Participants with Suspected Celiac Disease
EXPERIMENTALParticipants in this arm will receive a one-time dose of 250 mg of HB-2121.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 75 years
- Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease
- Body Mass Index (BMI) between 18 and 45 kg/m2
- Creatinine \<1.5 x Upper Limit of the Normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL x (ULN)
- Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) \& Alanine Aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN
- Overall good health, as determined by medical history and a physical exam
- No use of an investigational drug within 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
You may not qualify if:
- Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period
- History of cancer or malignancy
- History of chemotherapy and/or pelvic radiation
- History of congenital long QT syndrome or prolonged QTcF interval
- Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves
- 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
- History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Medicine Clinical and Translational Research Unit (CTRU)
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor, Medicine - Gastroenterology & Hepatology
Study Record Dates
First Submitted
January 9, 2026
First Posted
January 30, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 20, 2026
Record last verified: 2025-07