Celiac DiseasePhase 1NCT07063823
A First-in-human 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 and Healthy, 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. It will also look at how the body processes the drug. The main questions it aims to answer are: What side effects do participants have after receiving HB-2121? How much HB-2121 is in the blood over time? Researchers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Healthy
- 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 7 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- History of chemotherapy or pelvic radiation
- History of congenital long QT syndrome or prolonged QTcF interval
- 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
- Active cancer or history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug. The main questions it aims to answer are:
- What side effects do participants have after receiving HB-2121?
- How much HB-2121 is in the blood over time?
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
- 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, Healthy
- Being tested
- HB-2121
- Keywords
- Celiac Disease, HB-2121, Healthy Volunteers, Gluten Intolerance
- 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 |
|---|---|---|
| 50 mg HB-2121 in Healthy Volunteers | Experimental | Participants in this arm will receive a one-time dose of 50 mg of HB-2121. Receives: Drug: HB-2121 |
| 150 mg HB-2121 in Healthy Volunteers | Experimental | Participants in this arm will receive a one-time dose of 150 mg of HB-2121. Receives: Drug: HB-2121 |
| 250 mg HB-2121 in Healthy Volunteers | Experimental | Participants in this arm will receive a one-time dose of 250 mg of HB-2121. Receives: Drug: HB-2121 |
| 50 mg HB-2121 in Participants with Celiac Disease | Experimental | Participants in this arm will receive a one-time dose of 50 mg of HB-2121. Receives: Drug: HB-2121 |
| 150 mg HB-2121 in Participants with Celiac Disease | Experimental | Participants in this arm will receive a one-time dose of 150 mg of HB-2121. Receives: Drug: HB-2121 |
| 250 mg HB-2121 in Participants with 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) v5.0.
Measured: From dosing through 30 days post-dose
Secondary outcomes (3)
Peak Plasma Concentration (Cmax) of HB-2121
Blood samples will be collected at specified time points to determine the peak plasma concentration (Cmax) of HB-2121 following administration.
Measured: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Time to Peak Plasma Concentration (Tmax) of HB-2121
Time to reach the maximum plasma concentration (Tmax) of HB-2121 will be determined from blood sample data collected at specified time points.
Measured: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Area Under the Plasma Concentration-Time Curve (AUC) for HB-2121
The area under the plasma concentration versus time curve (AUC) for HB-2121 will be calculated using plasma concentration data from collected blood samples.
Measured: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start26 Aug 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT07063823
- Sponsor's protocol ID
- IRB-80209
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- 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-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
- ClinicalTrials.gov ID
- NCT07063823
- Acronym / sponsor ID
- IRB-80209
- Conditions
- Celiac Disease, Healthy
- Keywords
- Celiac Disease, HB-2121, Healthy Volunteers, Gluten Intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- 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
- 26 Aug 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 14 Jul 2025 (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. It will also look at how the body processes the drug. The main questions it aims to answer are:
- What side effects do participants have after receiving HB-2121?
- How much HB-2121 is in the blood over time?
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
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 50 mg HB-2121 in Healthy Volunteers | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 50 mg of HB-2121. |
| 150 mg HB-2121 in Healthy Volunteers | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 150 mg of HB-2121. |
| 250 mg HB-2121 in Healthy Volunteers | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 250 mg of HB-2121. |
| 50 mg HB-2121 in Participants with Celiac Disease | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 50 mg of HB-2121. |
| 150 mg HB-2121 in Participants with Celiac Disease | Experimental | Drug: HB-2121Participants in this arm will receive a one-time dose of 150 mg of HB-2121. |
| 250 mg HB-2121 in Participants with 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- History of chemotherapy or pelvic radiation
- History of congenital long QT syndrome or prolonged QTcF interval
- Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease
- Current use of immunosuppressant medications
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 | 150 mg HB-2121 in Healthy Volunteers, 150 mg HB-2121 in Participants with Celiac Disease, 250 mg HB-2121 in Healthy Volunteers, 250 mg HB-2121 in Participants with Celiac Disease, 50 mg HB-2121 in Healthy Volunteers, 50 mg HB-2121 in Participants with 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) v5.0.
3 secondary outcomes
Peak Plasma Concentration (Cmax) of HB-2121
Time frame: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Time to Peak Plasma Concentration (Tmax) of HB-2121
Time frame: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Area Under the Plasma Concentration-Time Curve (AUC) for HB-2121
Time frame: Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Healthy, 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 0 inclusion and 7 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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.