| Trial ID: | L5777 |
| Source ID: | NCT06783309
|
| Associated Drug: |
Cnp-103
|
| Title: |
CNP-103 in Adolescent and Adult Subjects Ages 12-35 with Recently Diagnosed (within 6 Months) Stage 3 Type 1 Diabetes (T1D)
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus|T1D|T1DM|T1DM - Type 1 Diabetes Mellitus|Type 1 Diabetes in Adolescence|Type 1 Diabetes in Children|Type 1 Diabetes (Juvenile Onset)|Type 1 Diabetes|Type 1 Diabetes Patients|Type 1 Diabetes Mellitis
|
| Interventions: |
DRUG: CNP-103|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety, Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 23.0 (CTCAE v. 5.0) or current, Day 1 Through Day 180|Immune Safety, Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10, Day 1 Through Day 180 |
|
| Sponsor/Collaborators: |
Sponsor: COUR Pharmaceutical Development Company, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-04
|
| Completion Date: |
2027-06
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-13
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06783309
|
