drugset / Trial / NCT03624062
MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes
Phase 1
Completed
21 enrolled
University of Colorado, Denver
Nova Immunotherapeutics Limited · collabThe Leona M. and Harry B. Helmsley Charitable Trust · collab
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2020-08-31
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MER3101 | Vaccine | 33 ug | Intramuscular |
| Subject | MER3101 | Vaccine | 109 ug | Intramuscular |
| Subject | MER3101 | Vaccine | 327 ug | Intramuscular |