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

Nielsen Fernandez-Becker

Status and phase: Enrolling; Phase 1

Conditions: Healthy; Celiac Disease

Treatments: Drug: HB-2121

Study type: Interventional

Funder types: Other

Identifiers

NCT07063823

IRB-80209

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. 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

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

50 mg HB-2121 in Healthy Volunteers

Experimental group

Description:

Participants in this arm will receive a one-time dose of 50 mg of HB-2121.

Treatment:

Drug: HB-2121

150 mg HB-2121 in Healthy Volunteers

Experimental group

Description:

Participants in this arm will receive a one-time dose of 150 mg of HB-2121.

Treatment:

Drug: HB-2121

250 mg HB-2121 in Healthy Volunteers

Experimental group

Description:

Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

Treatment:

Drug: HB-2121

50 mg HB-2121 in Participants with Celiac Disease

Experimental group

Description:

Participants in this arm will receive a one-time dose of 50 mg of HB-2121.

Treatment:

Drug: HB-2121

150 mg HB-2121 in Participants with Celiac Disease

Experimental group

Description:

Participants in this arm will receive a one-time dose of 150 mg of HB-2121.

Treatment:

Drug: HB-2121

250 mg HB-2121 in Participants with Celiac Disease

Experimental group

Description:

Participants in this arm will receive a one-time dose of 250 mg of HB-2121.

Treatment:

Drug: HB-2121