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HB-2121 for Suspected Celiac Disease

This study is looking at HB-2121, taken once by mouth, to see how safe it is and what side effects it might cause in adults who are suspected of having celiac disease. Researchers also want to understand how HB-2121 affects the small intestine. The main goal is to track any side effects and see how the drug interacts with the body. You may be eligible if you are between 18 and 75 years old, have a BMI between 18 and 45, and are scheduled for an EGD (a procedure to look at your esophagus, stomach, and small intestine) for suspected celiac disease. Researchers will follow participants for 30 days after taking HB-2121. The current status of this study is unclear, and it plans to enroll 20 people.

Study design
This is an interventional study planning to enroll 20 participants. It is a first-in-patient study to evaluate the safety and tolerability of HB-2121.
What's involved
You would receive one oral dose of HB-2121 four hours before your EGD. You would also attend 4 in-person clinic visits and complete 2 remote visits for checkups and lab tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after receiving HB-2121.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07377565

A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Nielsen Fernandez-Becker
~20 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:HB-2121

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of adverse events during the study window
Measured over From dosing through 30 days post-dose

Conditions

Celiac Disease

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Celiac Disease

NCT07377565

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Stanford, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Joaquin Tabera
[email protected]
(650) 334-1308
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Frequency and severity of adverse events during the study windowFrom dosing through 30 days post-dose

    Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.