VTP-1000 in Adults With Celiac Disease

Conditions

• Celiac Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• VTP-1000 — BIOLOGICAL
  Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
• Matched Placebo — OTHER
  Intramuscular (IM) injection comprised of saline solution

Study Details

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.

Key Dates

Start date

Aug 1, 2024

Status verified

Jun 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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
• Experimental: VTP-1000 Dose 1 (MAD)
  3 dose levels in SAD and MAD parts of trial
• Experimental: VTP-1000 Dose 2 (MAD)
  3 dose levels in SAD and MAD parts of trial
• Experimental: VTP-1000 Dose 3 (MAD)
  3 dose levels in SAD and MAD parts of trial

Primary Outcome Measure

Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs) [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]

Locations (16)

Find similar trials in Los Angeles, CA

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