NCT07377565 A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
| NCT ID | NCT07377565 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nielsen Fernandez-Becker |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-04-29 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07377565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07377565 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07377565 currently recruiting?
Yes, NCT07377565 is actively recruiting participants. Contact the research team at jtabera7@stanford.edu for enrollment information.
Where is the NCT07377565 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT07377565 clinical trial?
NCT07377565 is sponsored by Nielsen Fernandez-Becker. The trial plans to enroll 20 participants.