Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04279613 | A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041 | PHASE1 | COMPLETED | 47 | — | — | Nov 23, 2020 | Apr 24, 2024 | May 20, 2025 | 16 | United States |
Number of adverse events recorded during the on-treatment period, which is defined as from first treatment through visit 15 (or 5 weeks after last treatment for subjects not receiving all injections)
| Arm | Type | Description |
|---|---|---|
| NNC0361-0041 | EXPERIMENTAL | Dosage form: 9 mg/ml Solution for injection Route of administration: Subcutaneous Initial dose/Unit dose strength(s)/Dosage level(s) in cohort 1: 1mg Additional doses in cohorts 2, 3, and 4: 5mg, 12.5mg and 25mg Dosing instructions: Once weekly on site |
| Placebo | PLACEBO_COMPARATOR | Dosage form: Solution for injection Route of administration: Subcutaneous Dosing instructions: Once weekly on site |
| Name | Type | Description |
|---|---|---|
| NNC0361-0041 | DRUG | Recombinant supercoiled plasmid encoding four human proteins: (pre-proinsulin (PPI), transforming growth factor β1 (TGF-β1), interleukin-10 (IL-10), and interleukin-2 (IL-2) is administered s.c. via syringe and needle. |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Willing to provide Informed Consent 2. Participants must live in a location with rapid access to emergency medical services 3. Age 18-45 years (both inclusive) at the time of signing informed consent 4. Must have a diagnosis of T1D for less than 48 months at randomization 5. ...