A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
NCT ID: NCT07063823
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2025-08-26
2026-04-15
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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50 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 50 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
150 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 150 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
250 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
50 mg HB-2121 in Participants with Celiac Disease
Participants in this arm will receive a one-time dose of 50 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
150 mg HB-2121 in Participants with Celiac Disease
Participants in this arm will receive a one-time dose of 150 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
250 mg HB-2121 in Participants with Celiac Disease
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
HB-2121
HB-2121 taken once orally.
Interventions
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HB-2121
HB-2121 taken once orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Stanford's Innovative Medicines Accelerator
UNKNOWN
Nielsen Fernandez-Becker
OTHER
Responsible Party
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Nielsen Fernandez-Becker
Clinical Professor, Medicine - Gastroenterology & Hepatology
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Other Identifiers
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IRB-80209
Identifier Type: -
Identifier Source: org_study_id
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