HB-2121 for Celiac Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, HB-2121, to determine its safety for individuals who might have celiac disease. The trial focuses on identifying any side effects and understanding how HB-2121 interacts with the small intestine. Participants will take one dose of the drug and undergo monitoring through a series of clinic visits and follow-ups. Suitable candidates for this trial are those scheduled for an esophagogastroduodenoscopy (a scope to check the digestive tract) because their doctor suspects celiac disease. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using immunosuppressant medications.
Is there any evidence suggesting that HB-2121 is likely to be safe for humans?
Research has shown that HB-2121 is still new, with limited safety information from human studies. However, before human testing, researchers conducted thorough safety tests on animals. These tests indicated that any side effects were expected to be mild to moderate and temporary.
As HB-2121 is in early human trials, researchers are closely monitoring its effects on people. They will check for any side effects and interactions with the body, particularly the small intestine. Participants in this study will be monitored for 30 days to gather safe and reliable information.12345Why do researchers think this study treatment might be promising?
Most treatments for celiac disease focus on strict gluten-free diets. But HB-2121 is different because it's designed to directly target the immune response triggered by gluten. This could mean fewer dietary restrictions for patients in the future. Researchers are excited because it offers a new way to manage celiac disease that doesn't solely rely on avoiding gluten. This unique approach could significantly improve quality of life for those affected by the condition.
What evidence suggests that HB-2121 might be an effective treatment for celiac disease?
Research has shown that HB-2121, which participants in this trial will receive, may help with celiac disease by affecting the immune system. This is important because it might reduce symptoms without requiring complete gluten avoidance. Although HB-2121 has not been tested in people yet, early lab results suggest it could help manage the disease. Scientists are studying its effects in the small intestine, which is crucial for understanding its potential benefits. While no human data exists yet, the drug's mechanism appears promising as a new treatment for celiac disease.12345
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of HB-2121 four hours before their standard-of-care esophagogastroduodenoscopy
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nielsen Fernandez-Becker
Lead Sponsor
Stanford's Innovative Medicines Accelerator
Collaborator
Citations
NCT07063823 | A First-in-human Study to Evaluate the ...
The area under the plasma concentration versus time curve (AUC) for HB-2121 will be calculated using plasma concentration data from collected blood samples. ...
A First-in-Patient Study to Evaluate the Safety and ...
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 ...
Clinical Research Trial Listing ( 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.
HB-2121 for Celiac Disease
Researchers are excited because HB-2121 targets the underlying immune response, potentially reducing symptoms without the need to completely eliminate gluten.
Help Us Advance Celiac Disease Research
Risks: HB-2121 has not been tested in people before. The expected risks of HB-2121 are mild to moderate and temporary. The researchers completed thorough ...
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