VTP-1000 in Adults With Celiac Disease

NCT06310291 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: GLU001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (9)

• Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)

  Incidence and severity of treatment-emergent adverse events (TEAEs) , Serious Adverse Events (SAEs) , Adverse Events of Special Interest (AESIs) and adverse events leading to trial intervention discontinuation or trial withdrawal according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters

  Changes from baseline and clinically significant abnormalities in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters

  Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters

  Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters

  Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters

  Changes from baseline and clinically significant abnormalities in 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes from baseline and clinically significant abnormalities in vital signs

  Changes from baseline and clinically significant abnormalities in vital signs according to NCI CTCAE Version 5.0

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies

  Measurement of anti tTG immunoglobulin at screening and post treatment

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

• Changes in physical examination findings

  Full physical examination required at screening; symptom-directed physical examination at all other clinic visits. Each physical examination must include a review of the administration sites.

  Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Secondary Outcomes (13)

• PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component

  SAD Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

• PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component

  Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

• AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component

  Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

• AUC extrapolated to infinity (AUC0-∞)of rapamycin component

  Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

• Half-life of rapamycin component

  Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).

Other Outcomes (4)

• Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot)

  Part A (SAD): Day 1 pre-dose, Days 8 and 15 Part B (MAD): Day 1 pre-dose, Days 8, 22 and 36, Day 43 pre-challenge, Days 50 and 57

• T cell receptor (TCR) sequencing

  Part A (SAD): Day 1 pre-dose, Day 15 Part B (MAD): Day 1 pre-dose, Day 43 pre-challenge and Day 57

• Serum Cytokine Concentrations

  SAD Day 1 pre-dose, 4 hours and 24 hours postdose MAD: Days 1, 15 and 29 pre-dose and 4 hours post-dose

Study Arms (8)

Matched Placebo (SAD)

PLACEBO COMPARATOR

2 placebo comparators; 1 for each part of the study

Other: Matched Placebo

VTP-1000 Dose 1 (SAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

VTP-1000 Dose 2 (SAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

VTP-1000 Dose 3 (SAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

Matched Placebo (MAD)

PLACEBO COMPARATOR

2 placebo comparators; 1 for each part of the study

Other: Matched Placebo

VTP-1000 Dose 1 (MAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

VTP-1000 Dose 2 (MAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

VTP-1000 Dose 3 (MAD)

EXPERIMENTAL

3 dose levels in SAD and MAD parts of trial

Biological: VTP-1000

Interventions

VTP-1000 BIOLOGICAL

Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component

VTP-1000 Dose 1 (MAD); VTP-1000 Dose 1 (SAD); VTP-1000 Dose 2 (MAD); VTP-1000 Dose 2 (SAD); VTP-1000 Dose 3 (MAD); VTP-1000 Dose 3 (SAD)

Matched Placebo OTHER

Intramuscular (IM) injection comprised of saline solution

Matched Placebo (MAD); Matched Placebo (SAD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies less than 3 times the upper limit of normal
• Non-pregnant or breast feeding females
• No other clinical significant findings at screening

You may not qualify if:

• Refractory celiac disease
• Selective IgA deficiency
• Positive for HLA-DQ8
• Known wheat allergy or that is Type I hypersensitivity
• Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease

Sponsors & Collaborators

• Barinthus Biotherapeutics: lead

Study Sites (16)

Parexel EPCU LA

Los Angeles, California, 91206, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

GCP Research

St. Petersburg, Florida, 33705, United States

RECRUITING

Parexel EPCU Baltimore

Baltimore, Maryland, 21225, United States

RECRUITING

Clinical Research Institute of Michigan

Clinton Township, Michigan, 48038, United States

RECRUITING

West Michigan Clinical Research Center

Wyoming, Michigan, 49159, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Langone - Gastroenterology Associates

New York, New York, 10016, United States

RECRUITING

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

RECRUITING

Centricity Research

Columbus, Ohio, 43213, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

PPD Research Unit

Austin, Texas, 78744, United States

RECRUITING

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

RECRUITING

Clinical Research Partners

Richmond, Virginia, 23226, United States

RECRUITING

Velocity Clinical Research, Seattle

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)