NCT03624062

Brief Summary

The study is a randomized, double-masked, placebo-controlled, Phase 1 dose-escalation clinical trial. The objective of the trial is to determine if IBC adjuvanted with MAS-1 is safe and will favor tolerogenic pathways to restore immunologic balance and reverse type 1 diabetes (T1D) autoimmunity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

July 23, 2018

Last Update Submit

February 10, 2026

Conditions

Type 1 Diabetes Mellitus

Keywords

New onset

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Number of participants with Treatment-Related Adverse Events, and the frequency of Adverse Events, as Assessed by CTCAE v4.0. The rates of severe hypoglycemic and adverse events will be computed (total number of events divided by total patient years of follow-up) and the rates compared using a Poisson regression model.

    43 months

  • Immunologic Analysis

    T cell assays looking for IL-4, IL-5, IL-10, IL-13, TGFβ production and shift towards Treg and iNKT cell population.

    43 months

Secondary Outcomes (3)

  • Mean C-peptide AUC value

    43 months

  • HbA1c value

    43 months

  • Insulin Use

    43 months

Study Arms (3)

33 ug IBC in 0.25 mL MAS-1 emulsion

OTHER

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 33 ug IBC dose in 0.25 mL MAS-1 emulsion

Drug: MAS-1 adjuvanted Insulin B-chain

109 ug IBC in 0.25 mL MAS-1 emulsion

OTHER

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 109 ug IBC dose in 0.25 mL MAS-1 emulsion

Drug: MAS-1 adjuvanted Insulin B-chain

327 ug IBC in 0.25 mL MAS-1 emulsion

OTHER

7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 327 ug IBC dose in 0.25 mL MAS-1 emulsion

Drug: MAS-1 adjuvanted Insulin B-chain

Interventions

MAS-1 adjuvanted Insulin B-chainDRUG

MER3101 (MAS-1 adjuvanted insulin B chain (IBC)), is a white, free-flowing 30:70 (w/w) water-in-oil (W/O) emulsion. MER3101 contains in the aqueous (disperse) phase 33, 109, or 327 µg per 0.25 mL dose of IBC (Drug Substance) and the oil (continuous) phase is comprised of MAS-1 oil vehicle.

109 ug IBC in 0.25 mL MAS-1 emulsion327 ug IBC in 0.25 mL MAS-1 emulsion33 ug IBC in 0.25 mL MAS-1 emulsion

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 and 45 years of age who meet the ADA standard T1DM criteria and are positive for at least 1 islet cell autoantibody.
  • Type 1-diabetes mellitus diagnosed within the previous 2 years at time of screening
  • Must have stimulated C-peptide levels ≥ 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
  • At least one month from last immunization
  • Must be willing to comply with intensive diabetes management
  • If participant is female with reproductive potential, she must have a negative pregnancy test and be willing to avoid pregnancy during the treatment period until 2 months after the last study drug administration.
  • Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration (COVID-19 vaccination is permitted 60 days following initial study drug administration)
  • Subjects must have HbA1c levels under 9.5 to be enrolled in the study.
  • At least 30 days from receiving a single dose COVID-19 vaccine or at least 30 days from completing a multi-dose COVID-19 vaccine series.

You may not qualify if:

  • Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration.
  • Ongoing use of medications known to influence glucose tolerance
  • Require use of systemic immunosuppressant(s)
  • Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy
  • Have a history of malignancies
  • Be currently using non-insulin pharmaceuticals to affect glycemic control
  • Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological abnormalities.
  • Inability or unwillingness to comply with the provisions of this protocol
  • Have an active infection or positive tuberculosis test result.
  • Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
  • Have a known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen
  • Subjects with a history or evidence of chronic kidney disease (serum creatinine\> 1.5mg/dL)
  • Subjects with a history of proliferative diabetic retinopathy that has not been treated with laser therapy
  • Subjects with a history of neuropathy, foot ulcers, amputations, or kidney disease
  • Males of reproductive potential who are unwilling to use acceptable birth control during the treatment period through 2 months after the last study drug administration, unless the female partner is postmenopausal or surgically sterile.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Peter Gottlieb

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 9, 2018

Study Start

August 31, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)