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

Testing HB-2121's safety for diagnosing Celiac Disease.

Recruiting
18 years and older
All
Phase 1

This clinical trial is testing a new drug called HB-2121, used as a diagnostic tool for celiac disease. Celiac disease is an illness where eating gluten (a protein found in wheat, barley, and rye) causes problems in the small intestine. The study will evaluate how safe a single dose of HB-2121 is and how the body handles it. Participants will take one oral dose and be monitored for 30 days. They need to visit the clinic 4 times and have 2 remote check-ins. They'll also answer a daily survey for a week about their health.

Key Points:

  • Study duration: 30 days with 4 in-person and 2 remote visits.
  • Participants receive a single oral dose of HB-2121.
  • Must be healthy, aged 18+, and able to eat gluten without issues, if not celiac.

To join, participants should not have serious health issues or be pregnant. Those with celiac must have a confirmed diagnosis. The study checks for any side effects and measures the drug in the blood over time.

Study details
    Celiac Disease
    Healthy

NCT07063823

Nielsen Fernandez-Becker

17 April 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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