Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
High Dose SAB-142 · 1 trial · 1 indication
This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\] at 12 months)
| Arm | Type | Description |
|---|---|---|
| High Dose SAB-142 | EXPERIMENTAL | Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised. |
| Low Dose SAB-142 | EXPERIMENTAL | Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised. |
| Placebo | PLACEBO_COMPARATOR | Part B: This is a double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised. |
| Name | Type | Description |
|---|---|---|
| High Dose SAB-142 | DRUG | High Dose SAB-142 |
| Low Dose SAB-142 | DRUG | Low Dose SAB-142 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Participant and/or appropriate legal guardian must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of...