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Guest article by Marissa Dobry, Research Associate, Clinical Trials, and Joaquin Tabera, Clinical Research Coordinator, both with the Innovative Medicines Accelerator (IMA) at Stanford University
Lighting up the gut to detect celiac disease
Stanford researchers are launching a first-in-human research study of HB-2121, a new diagnostic agent designed to help detect and monitor celiac disease in the absence of eating gluten. Led by gastroenterologists Nielsen Fernandez-Becker, MD, PhD, director of the Celiac Disease Program, and Nasim Khavari, MD, MPH, this study could pave the way for simpler, more accurate testing. Researchers are currently looking for volunteers to help make it possible.
What is HB-2121, and why does it matter?
HB-2121 is a new investigational drug developed at Stanford. Harrison Besser, an MD/PhD student studying in the lab of Chaitan Khosla, PhD, developed the molecule during his PhD thesis. The Stanford University Innovative Medicines Accelerator continued development of HB-2121 to enable the upcoming research study.
HB-2121 targets transglutaminase 2 (TG2)—an enzyme that plays a central role in celiac disease. TG2 is mostly inactive in healthy people and doesn’t react strongly to gluten. But in people with celiac disease, TG2 becomes highly active, especially when gluten is in the diet. This enzyme changes gluten in a way that causes the immune system to mistake it for a threat, leading to inflammation and damage in the small intestine.
HB-2121 is taken orally, mixed with water. Once swallowed, it binds to active TG2 in the gut. By “lighting up” this enzyme, it allows researchers to detect where and how much TG2 is active. This could help doctors better understand how celiac disease behaves, even in people who are on a strict gluten-free diet but still experience symptoms. In the long run, HB-2121 may become an important tool not just for diagnosis, but also for monitoring disease and evaluating new treatments.
How the research study works
This Phase 1a research study is the first time HB-2121 is being tested in people. The study aims to enroll 18 to 36 adults, including both individuals diagnosed with celiac disease and healthy volunteers.
After providing informed consent and passing eligibility screening, participants will consume a single dose of HB-2121 dissolved in a bottle of drinking water. They will then be monitored at the clinic for six hours after receiving the dose.
Follow-up visits will be scheduled for the next morning and one week later, each lasting approximately one hour. Additionally, remote telehealth visits will occur 15 and 30 days after receiving the dose, with laboratory tests conducted at locations convenient for the participants. Throughout the first 1-7 days after receiving the dose, participants will complete a short daily questionnaire to report any symptoms or changes in their health.
All in-person visits will take place at Stanford’s Clinical and Translational Research Unit (CTRU), located at 800 Welch Road, Palo Alto, CA 94304.
All participants who complete the study will receive a total of $400 in gift cards as appreciation for their time.
Learn more
If you’d like to learn more about the research study and consider participating, please contact Joaquin Tabera, Clinical Research Coordinator at Stanford’s Innovative Medicines Accelerator, at (650) 334-1308 or jtabera7@stanford.edu. The study team looks forward to receiving your inquiry.
View details of the HB-2121 study on the Studypage and ClinicalTrials.gov (NCT07063823).
For participant’s rights questions, contact 1-866-680-2906.
The Celiac Community Foundation of Northern California is providing recruitment assistance for this research study as a pro bono public service to advance research that may benefit our community. We have no financial relationship with the study.
