Clinical trial

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

ID

Name

GLU001

Description

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.

Trial arms

Trial start

2024-04-01

Estimated PCD

2025-08-01

Trial end

2025-08-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

VTP-1000

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

Arms:

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

Intramuscular (IM) injection comprised of saline solution

Arms:

Matched Placebo (MAD), Matched Placebo (SAD)

Size

45

Primary endpoint

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.

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 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.

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.

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.

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 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.

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.

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.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

1 product

1 indication

Organization

Barinthus Biotherapeutics

Product

Indication