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New oral diagnostic for celiac disease passes first safety check

NCT ID NCT07063823

Diagnosis Sponsor: Nielsen Fernandez-Becker Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This early-stage study tested whether a single oral dose of HB-2121 is safe in adults. Researchers monitored 18 participants for side effects and tracked how the drug moves through the body over 30 days. The goal is to develop a new way to diagnose celiac disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General Inclusion Criteria (applies to all participants): * Aged 18 years and older * Body Mass Index (BMI) between 18 and 45 kg/m2 * Overall good health, as determined by medical history and a physical exam * No use of an investigational drug in the past 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 Additional Inclusion Criteria for Healthy Volunteers: * No diagnosis of celiac disease * No first-degree relatives (parent, sibling, child) with celiac disease * Able to eat gluten-containing foods without adverse effects * No history of autoimmune gastrointestinal disorders such as Crohn's disease, ulcerative colitis, or eosinophilic enteritis Additional Inclusion Criteria for Participants with Celiac Disease: * Biopsy-confirmed diagnosis of celiac disease * No history of eosinophilic enteritis, autoimmune gastrointestinal disorders such as Crohn's disease or inflammatory bowel disease Exclusion Criteria (applies to all participants): * 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

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease Healthy

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.