Recruiting
Phase 1

HB-2121

Sponsor:

Nielsen Fernandez-Becker

Code:

NCT07377565

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HB-2121

Study Details

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

Conditions

Celiac Disease

Study ID

NCT07377565

Start date

Apr 29, 2026

Status verified date

Jul, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 250 mg HB-2121 in Participants with Suspected Celiac Disease

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

Interventions

HB-2121

HB-2121 taken once orally.

Primary outcome measure

  • Frequency and severity of adverse events during the study window [ Time Frame: From dosing through 30 days post-dose ]

Central Contacts and Locations

Central contacts

Joaquin Tabera

(650) 334-1308jtabera7@stanford.edu

Marissa Dobry

(313) 320-2240mdobry@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Nielsen Fernandez-Becker

Last update posted

Jul 28, 2026

Last verified

Jul, 2025

Keywords

  • Celiac Disease
  • HB-2121
  • Gluten Intolerance
  • Esophagogastroduodenoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nielsen Fernandez-Becker on 2026-07-28.