NCT03624062

MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a four-arm (cohort), single center, randomized, double-masked, placebo-controlled, dose-escalation clinical trial. In this Phase I study, subjects (5 active MER3101 per arm plus 2 MAS-1 placebo) will be randomized to receive two intramuscular doses at days 0 and 28 of either MAS-1 placebo emulsion or MAS-1 adjuvanted IBC at 33, 109, and 327 µg IBC in 0.25 mL MAS-1 adjuvanted emulsion, followed by an additional arm to receive the optimal IBC dose selected from the first 3 arms in 0.25 mL MAS-1 emulsion. All groups will receive standard intensive diabetes treatment with insulin and dietary management. The primary endpoint is assess the safety and tolerability of 3 doses of progressively higher IBC antigen doses of the vaccine, at 0.25 mL of MAS-1 adjuvant emulsion. In addition, to determine if the vaccine induces a shift towards protection shown by increased levels of IL-4, IL-5, IL-10 and TGF-b and regulatory changes in insulin-specific T and B cells using novel reagents to detect these unique populations of cells in treated subjects.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	MAS-1 adjuvanted Insulin B-chain	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.

Timeline

• Start date: 2020-08-31
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2018-08-09
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study