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 people with celiac disease and healthy volunteers. The trial aims to identify potential side effects and understand how the drug moves through the body. Participants will take a single dose and undergo close monitoring for 30 days. Those with celiac disease must have a biopsy-confirmed diagnosis and manage daily life on a gluten-free diet. Healthy volunteers should have no history of celiac disease or autoimmune gut disorders. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently using immunosuppressant medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that HB-2121 is currently being tested for safety in humans. As this is the first human trial of HB-2121, no prior safety information exists. The trial is in its early stages, focusing on assessing how well participants tolerate the treatment. Researchers closely monitor for any side effects or unexpected reactions during these initial trials.
Participants receive a single dose of HB-2121 and are observed for 30 days to identify any potential side effects. This vigilant monitoring ensures that any issues are quickly detected. Although no existing safety data on HB-2121 is available, the trial is designed to thoroughly investigate this aspect.12345Why are researchers excited about this trial's treatment?
Unlike the standard treatments for celiac disease, which typically involve strict adherence to a gluten-free diet, HB-2121 offers a novel approach. Researchers are excited because HB-2121 targets the underlying immune response, potentially reducing symptoms without the need to completely eliminate gluten. This treatment involves a one-time dose, which could simplify management of the condition compared to lifelong dietary restrictions. If successful, HB-2121 could significantly improve the quality of life for individuals with celiac disease by addressing the root cause rather than just managing symptoms.
What evidence suggests that this trial's treatments could be effective for Celiac Disease?
Research shows that HB-2121 targets an enzyme called transglutaminase 2 (TG2), which plays a crucial role in celiac disease. In healthy individuals, TG2 remains mostly inactive, but in those with celiac disease, it activates and triggers inflammation when gluten is consumed. By targeting this enzyme, HB-2121 aims to reduce inflammation and manage celiac disease symptoms. Although limited human data exists, its mechanism suggests potential benefits for those with the condition. Early signs appear promising, but further studies are necessary to confirm its effectiveness.14678
Are You a Good Fit for This Trial?
This trial is for adults with Celiac Disease or healthy individuals interested in helping to test a new diagnostic drug, HB-2121. Participants will need to attend several clinic visits and complete remote assessments.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 and are monitored for immediate effects
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood sample collection and adverse event monitoring
What Are the Treatments Tested in This Trial?
Interventions
- HB-2121
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nielsen Fernandez-Becker
Lead Sponsor
Stanford's Innovative Medicines Accelerator
Collaborator