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

Nielsen Fernandez-Becker

Status and phase

Begins enrollment in 2 months

Phase 1

Conditions

Celiac Disease

Treatments

Drug: HB-2121

Study type

Interventional

Funder types

Other

Identifiers

NCT07377565

Pending

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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