A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

Phase 1Not Yet RecruitingNCT07377565

Nielsen Fernandez-Becker20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Celiac Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency and severity of adverse events during the study window

Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame: From dosing through 30 days post-dose

Secondary Outcomes

Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view.

Endoscopic biopsy samples will be collected after dosing, and fresh frozen tissue sections will be stained with DAPI and analyzed using a confocal microscope to determine the fluorescence intensity of sulfo-Cy5 and DAPI.

Time frame: 240 minutes after dosing

Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count.

Endoscopic biopsy samples will be collected after dosing, and the paraffin-embedded tissue sections will be stained with hematoxylin and eosin, as well as CD3, and analyzed using a microscope to determine villus height, crypt depth, and the number of CD3+ intraepithelial lymphocytes.