NCT07377565招募中1 期
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Nielsen Fernandez-Becker1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events during the study window
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
250 mg HB-2121 in Participants with Suspected Celiac Disease
Experimental
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
干预措施: HB-2121 (Drug)
结局指标
主要结局
Frequency and severity of adverse events during the study window
时间窗: 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) v6.0.
次要结局
- Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view.(At least 120 minutes after dosing)
- Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count.(At least 120 minutes after dosing)
- Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view.(240 minutes after dosing)
- Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count.(240 minutes after dosing)
研究者
Nielsen Fernandez-Becker
Clinical Professor, Medicine - Gastroenterology & Hepatology
Stanford University
研究点 (1)
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