A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Frequency and severity of adverse events during the study window
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
150 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 150 mg of HB-2121.
Intervention: HB-2121 (Drug)
50 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 50 mg of HB-2121.
Intervention: HB-2121 (Drug)
250 mg HB-2121 in Healthy Volunteers
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
Intervention: HB-2121 (Drug)
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.
Intervention: HB-2121 (Drug)
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.
Intervention: HB-2121 (Drug)
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.
Intervention: HB-2121 (Drug)
Outcomes
Primary Outcomes
Frequency and severity of adverse events during the study window
Time Frame: 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 Outcomes
- 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.)
- 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.)
- 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.)
Investigators
Nielsen Fernandez-Becker
Clinical Professor, Medicine - Gastroenterology & Hepatology
Stanford University