HB-2121 for Celiac Disease

Overseen By Joaquin Tabera

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nielsen Fernandez-Becker

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Cancer, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Adults aged 18-75 with suspected celiac disease, planning to undergo an esophagogastroduodenoscopy (EGD), can join this trial. They should have a BMI of 18-45, normal kidney and liver function tests, be in good health overall, not have used investigational drugs recently, and agree to use effective birth control if they can have children.

Inclusion Criteria

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)

Exclusion Criteria

I have had cancer before.

Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period

History of congenital long QT syndrome or prolonged QTcF interval

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of HB-2121 four hours before their standard-of-care esophagogastroduodenoscopy

1 day

1 visit (in-person)

Monitoring

Participants attend 4 in-person clinic visits and 2 remote visits for checkups, lab tests, and monitoring, and fill out a daily questionnaire for 7 days

7 days

4 visits (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• HB-2121

Trial Overview

The study is testing the safety of HB-2121 when given as a single oral dose before an EGD procedure in people who might have celiac disease. It will monitor how the drug interacts with the small intestine and track any side effects for up to 30 days post-dose through clinic visits and remote check-ins.

How Is the Trial Designed?

Group I: 250 mg HB-2121 in Participants with Suspected Celiac Disease Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Nielsen Fernandez-Becker

Lead Sponsor

Trials

1

Recruited

10+

Stanford's Innovative Medicines Accelerator

Collaborator

Trials

1

Recruited

20+