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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of celiac disease as confirmed by positive serology and intestinal histology
• Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype
• Participants who are on a well controlled gluten restricted diet
• Negative or weak positive anti-tissue transglutaminase (tTG) IgA antibodies and negative or weak positive anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies
• Non-pregnant or breast feeding females
• No other clinical significant findings at screening
Locations
United States
California
Parexel EPCU LA
RECRUITING
Los Angeles
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
GCP Research
RECRUITING
St. Petersburg
Maryland
Parexel EPCU Baltimore
RECRUITING
Baltimore
Michigan
Clinical Research Institute of Michigan
RECRUITING
Clinton Township
West Michigan Clinical Research Center
RECRUITING
Wyoming
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
North Carolina Clinical Research
RECRUITING
Raleigh
New York
NYU Langone - Gastroenterology Associates
NOT_YET_RECRUITING
New York
Ohio
Centricity Research
RECRUITING
Columbus
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
PPD Research Unit
RECRUITING
Austin
Utah
Velocity Clinical Research, Salt Lake City
RECRUITING
West Jordan
Virginia
Clinical Research Partners
RECRUITING
Richmond
Washington
Velocity Clinical Research, Seattle
RECRUITING
Seattle
Time Frame
Start Date:2024-08-01
Estimated Completion Date:2026-06
Participants
Target number of participants:45
Treatments
Placebo_comparator: Matched Placebo (SAD)
2 placebo comparators; 1 for each part of the study
Experimental: VTP-1000 Dose 1 (SAD)
3 dose levels in SAD and MAD parts of trial
Experimental: VTP-1000 Dose 2 (SAD)
3 dose levels in SAD and MAD parts of trial
Experimental: VTP-1000 Dose 3 (SAD)
3 dose levels in SAD and MAD parts of trial
Placebo_comparator: Matched Placebo (MAD)
2 placebo comparators; 1 for each part of the study