A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB-2121.
- Who it may be relevant to
- Registry conditions: Celiac Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug HB-2121
HB-2121 taken once orally.
Primary outcome measures
- Frequency and severity of adverse events during the study window [Time frame: From dosing through 30 days post-dose]
Secondary outcome measures (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. [Time frame: At least 120 minutes after dosing]
- Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count. [Time frame: At least 120 minutes after dosing]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT07377565 · 84052