Celiac Disease, Healthy
Conditions
Keywords
Celiac Disease, HB-2121, Healthy Volunteers, Gluten Intolerance
Brief 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
Interventions
DRUGHB-2121
HB-2121 taken once orally.
Sponsors
Nielsen Fernandez-Becker
Stanford's Innovative Medicines Accelerator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of adverse events during the study window | From dosing through 30 days post-dose | Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of HB-2121 | Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing. | Blood samples will be collected at specified time points to determine the peak plasma concentration (Cmax) of HB-2121 following administration. |
| Time to Peak Plasma Concentration (Tmax) of HB-2121 | Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing. | Time to reach the maximum plasma concentration (Tmax) of HB-2121 will be determined from blood sample data collected at specified time points. |
| Area Under the Plasma Concentration-Time Curve (AUC) for HB-2121 | Pre-dose, and at 15, 30, 60, 120, 180, 240, and 360 minutes, and 1 day after dosing. | The area under the plasma concentration versus time curve (AUC) for HB-2121 will be calculated using plasma concentration data from collected blood samples. |
Countries
United States
Outcome results
None listed