VTP-1000 in Adults With Celiac Disease (NCT06310291)
A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease
🩺 Plain-English Summary (8th-Grade Level)
GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.
Who can join: Review the eligibility criteria below.
Location: Parexel EPCU LA — Los Angeles, California
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Parexel EPCU LA — Los Angeles, California
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- Jacksonville Center for Clinical Research — Jacksonville, Florida
- GCP Research — St. Petersburg, Florida
- Parexel EPCU Baltimore — Baltimore, Maryland
- Clinical Research Institute of Michigan — Clinton Township, Michigan
- West Michigan Clinical Research Center — Wyoming, Michigan
- Mayo Clinic — Rochester, Minnesota
- NYU Langone - Gastroenterology Associates — New York, New York
- North Carolina Clinical Research — Raleigh, North Carolina
- Centricity Research — Columbus, Ohio
- Vanderbilt University Medical Center — Nashville, Tennessee
- PPD Research Unit — Austin, Texas
- Velocity Clinical Research, Salt Lake City — West Jordan, Utah
- Clinical Research Partners — Richmond, Virginia
- Velocity Clinical Research, Seattle — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (626) 298-2756
Email: jess.mehrsaz@parexel.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Celiac Disease
- A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease — Murrieta, California
- A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease — Stanford, California
- Immune Responses to Gluten — Aurora, Colorado
- Tissue Destruction and Healing in Celiac Disease — Pasadena, California
- Gluten Technology and Education for Celiac Health — Chicago, Illinois
- Study of DONQ52 in Active Celiac Disease — Anniston, Alabama
Explore by condition: All Celiac Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.