Early access
Sign in
Taking people in United StatesPhase 1

Testing HB-2121 as a diagnostic aid in adults with suspected celiac disease

Tests the safety of one HB-2121 dose in adults with suspected celiac disease.

Key facts

Who runs it
Nielsen Fernandez-Becker
Where
Stanford, United StatesSee the site
Trial code
Registry title
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Status
Recruiting
Phase
Phase 1
People taking part
20 people, planned
Started
29 Apr 2026
Expected to end
1 Jun 2027
Type of study
Interventional
Treatments tested
  • HB-2121
Record updated
28 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with suspected celiac disease who are having an EGD (a camera test of the gut). They get one dose of HB-2121 by mouth before it.

Age
18 to 75 years
Sex
All sexes can join
Disease stage
Suspected celiac disease, with an esophagogastroduodenoscopy (EGD) planned as standard care
Earlier treatment
No investigational drug within 12 weeks. No past chemotherapy or pelvic radiation.
Biomarker or test result
BMI between 18 and 45 kg/m2. Creatinine < 1.5 x ULN. Total bilirubin ≤ 1.5 mg/dL x (ULN). AST and ALT ≤ 1.5 x ULN.

Main reasons for not taking part

  • Pregnant, breastfeeding or planning pregnancy during the study
  • History of cancer
  • Known HIV, hepatitis B or C, or other serious long-term liver disease
  • Current use of medicines that weaken the immune system
  • History of long QT syndrome, eosinophilic enteritis, Crohn's disease or ulcerative colitis

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current use of immunosuppressant medications
  • History of cancer or malignancy
  • History of chemotherapy and/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
  • History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis
  • History of congenital long QT syndrome or prolonged QTcF interval
  • Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period
  • Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves

Where in United States

  • Stanford UniversityStanford, United StatesContact: Joaquin TaberaTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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

The group in the trial

  • 250 mg HB-2121 in Participants with Suspected Celiac DiseaseTreatment being tested

    Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

    Treatment: HB-2121

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Plain-language title
Testing HB-2121 as a diagnostic aid in adults with suspected celiac diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
28 July 2026