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

Обзор

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

Вмешательства

• Препарат HB-2121
  HB-2121 taken once orally.

Первичные конечные точки

• Frequency and severity of adverse events during the study window [Срок оценки: From dosing through 30 days post-dose]

Вторичные конечные точки (2)

• Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view. [Срок оценки: At least 120 minutes after dosing]
• Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count. [Срок оценки: At least 120 minutes after dosing]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford University — Stanford

Идентификаторы

NCT: NCT07377565 · 84052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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