Celiac DiseasePhase 1NCT07377565
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
A Phase 1 study testing HB-2121 in people with Celiac Disease, run by Nielsen Fernandez-Becker at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- HB-2121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
About this study
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?
Read more
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
- Being tested
- HB-2121
- Keywords
- Celiac Disease, HB-2121, Gluten Intolerance, Esophagogastroduodenoscopy
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-2121Drug
HB-2121 taken once orally.
| Study group | Role | What they receive |
|---|---|---|
| 250 mg HB-2121 in Participants with Suspected Celiac Disease | Experimental | Participants in this arm will receive a one-time dose of 250 mg of HB-2121. Receives: Drug: HB-2121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events during the study window
Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: From dosing through 30 days post-dose
Secondary outcomes (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.
Endoscopic biopsy samples will be collected after dosing, and fresh frozen tissue sections will be stained with DAPI and analyzed using a confocal microscope to determine the fluorescence intensity of sulfo-Cy5 and DAPI.
Measured: At least 120 minutes after dosing
Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count.
Endoscopic biopsy samples will be collected after dosing, and the paraffin-embedded tissue sections will be stained with hematoxylin and eosin, as well as CD3, and analyzed using a microscope to determine villus height, crypt depth, and the number of CD3+ intraepithelial lymphocytes.
Measured: At least 120 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start29 Apr 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nielsen Fernandez-Becker
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford's Innovative Medicines Accelerator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, Nielsen Fernandez-Becker, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377565
- Sponsor's protocol ID
- 84052
- Status last verified
- Jul 2025
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
- ClinicalTrials.gov ID
- NCT07377565
- Acronym / sponsor ID
- 84052
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, HB-2121, Gluten Intolerance, Esophagogastroduodenoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nielsen Fernandez-BeckerUniversity, hospital or other
- Collaborators
- Stanford's Innovative Medicines Accelerator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 250 mg HB-2121 in Participants with Suspected Celiac Disease | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 250 mg of HB-2121. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-2121HB-2121 taken once orally. | Drug | 250 mg HB-2121 in Participants with Suspected Celiac Disease |
Primary outcome
Frequency and severity of adverse events during the study window
Time frame: From 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB-2121 in people with Celiac Disease, run by Nielsen Fernandez-Becker at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joaquin Tabera ((650) 334-1308, jtabera7@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events during the study window (time frame: From dosing through 30 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.