CompletedPhase 1

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

United States18 participantsStarted 2025-08-26

Plain-language 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 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency and severity of adverse events during the study window

Timeframe: From dosing through 30 days post-dose

Trial details

NCT IDNCT07063823

SponsorNielsen Fernandez-Becker

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-07

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