VTP-1000 in Adults With Celiac Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

VTP-1000: Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component

Matched Placebo: Intramuscular (IM) injection comprised of saline solution

Study 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

Primary outcome measure(s)

• Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs) — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  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
• Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters — 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 laboratory safety parameters according to NCI CTCAE Version 5.0
• Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
• Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0
• Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0
• Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters — 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 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0
• Changes from baseline and clinically significant abnormalities in vital signs — 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 according to NCI CTCAE Version 5.0
• Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  Measurement of anti tTG immunoglobulin at screening and post treatment
• Changes in physical examination findings — Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.
  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.

Trial sites (16)

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