Actively Recruiting
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Led by Nielsen Fernandez-Becker · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nielsen Fernandez-Becker
Lead Sponsor
S
Stanford's Innovative Medicines Accelerator
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a single oral dose of HB-2121 in adults with suspected celiac disease. This Phase 1 trial aims to understand what side effects participants may experience and how the drug interacts with the small intestine. The study is sponsored by Nielsen Fernandez-Becker and includes adults aged 18 to 75 undergoing diagnostic procedures for celiac disease. Participants will receive one 250 mg dose of HB-2121 four hours before a standard esophagogastroduodenoscopy (EGD). The study involves four in-person clinic visits for checkups and lab tests, along with two remote visits focusing on safety lab assessments. Participants will also complete a daily questionnaire for a week about their symptoms and overall health. During the 30 days following dosing, researchers will monitor safety by tracking any adverse events. They will also measure specific markers in the small intestine using microscopy shortly after dosing. The study includes regular health monitoring, laboratory tests, and questionnaires to assess participant well-being and drug behavior over the study period.
CONDITIONS
Brief Title
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease
- Body Mass Index (BMI) between 18 and 45 kg/m2
- Creatinine less than 1.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 mg/dL times the upper limit of normal
- AST/SGOT and ALT/SGPT less than or equal to 1.5 times the upper limit of normal
- Overall good health based on medical history and physical exam
- No use of investigational drugs within 12 weeks
- Able and willing to follow study procedures and provide written informed consent
- If of childbearing potential, agree to use highly effective birth control during the study; same applies to male participants with partners of childbearing potential
You will not qualify if you...
- Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study
- 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 unable to consent for themselves
- Known HIV infection or positive test for hepatitis B or C, or other 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 hours (240 minutes) after dosing
Participants receive a one-time oral dose of HB-2121 and undergo diagnostic assessments including confocal fluorescent microscopy and tissue measurements.
1 visit (in-person)
Duration - 30 days
Participants are monitored for safety and tolerability through 30 days after dosing.
Follow-up visits during the 30-day post-dose period
Trial Site Locations
Total: 1 location
1
Stanford Medicine Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
J
Joaquin Tabera
M
Marissa Dobry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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