First-in-patient safety test of HB-2121 for celiac disease diagnosis
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
This test gives a single oral dose of HB-2121 to adults having an EGD for suspected celiac disease to see if it is safe and how it interacts with the small intestine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT07377565 on ClinicalTrials.gov |
What this trial studies
This is a first-in-patient, single-dose Phase 1 safety study of HB-2121 in adults undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease. Participants will take one oral dose of HB-2121 four hours before their routine EGD, and researchers will collect tissue and safety data during and after the procedure. Subjects will be followed for 30 days with four in-person visits, two remote safety visits, lab tests, and a short daily symptom questionnaire for seven days. The study focuses on tolerability, side effects, and how the agent interacts with the small intestine.
Who should consider this trial
Good fit: Adults aged 18–75 with suspected celiac disease who are scheduled for EGD, have BMI 18–45 kg/m2, acceptable kidney and liver tests, and agree to study procedures and required contraception if applicable.
Not a fit: People who are pregnant, breastfeeding, have recent cancer, abnormal liver or kidney function beyond study limits, or are not scheduled for EGD are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, HB-2121 could provide a safe, targeted diagnostic marker to help identify celiac-related changes in the small intestine during routine endoscopy.
How similar studies have performed: This is a first-in-patient diagnostic agent and similar human data are limited, so the approach is largely novel in clinical use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford Medicine Clinical and Translational Research Unit (CTRU) — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Joaquin Tabera
- Email: jtabera7@stanford.edu
- Phone: (650) 334-1308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.