Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG019- Low Dose · 1 trial · 1 indication
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
| Arm | Type | Description |
|---|---|---|
| AG019 Cohort 1 - Low Dose/Adults | EXPERIMENTAL | - |
| AG019 Cohort 2 - High Dose/Adults | EXPERIMENTAL | - |
| AG019 Cohort 3 - Low Dose/Adolescents | EXPERIMENTAL | - |
| AG019 Cohort 4 - High Dose/Adolescents | EXPERIMENTAL | - |
| Combination Cohort 1 - Adults | EXPERIMENTAL | - |
| Combination Cohort 2 - Adolescents | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AG019 - Low Dose | BIOLOGICAL | Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose) |
| Teplizumab | DRUG | Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area). |
| Placebo-AG019 | DRUG | Formulated identically to AG019 with the active ingredient removed. |
| Placebo-Teplizumab | DRUG | Formulated identically to teplizumab with the active ingredient removed. |
| AG019 - High Dose | BIOLOGICAL | Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks |
Inclusion Criteria: * Male or non-pregnant, non-lactating females, 18 - 40 years of age (both inclusive) or 12-17 years of age (both inclusive) * Diagnosis of diabetes according to the American Diabetes Association (ADA) recommended criteria * Evidence of auto-antibodies to at least 1 β-cell autoan...
AG019 Low Dose is an investigational monoclonal antibody being studied for the treatment of diabetes type 1. It is intended for participants with recent-onset diagnosed type 1 diabetes. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
AG019 Low Dose is being developed by Precigen, Inc., a biopharmaceutical company traded under the ticker symbol PGEN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational therapy in patients with type 1 diabetes.
AG019 Low Dose is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory agencies. One Phase 1 clinical trial has been completed, and the drug is not currently in any active trials.
AG019 Low Dose was studied in a Phase 1 clinical trial with the identifier NCT03751007. This completed trial assessed the safety and tolerability of different doses of AG019, administered alone or in combination with teplizumab, in participants with recent-onset type 1 diabetes. The trial enrolled 45 participants in the United States and Belgium.
AG019 Low Dose is a specific dose level of the investigational drug AG019. The clinical trial NCT03751007 evaluated different doses of AG019, including a low dose, administered alone or with teplizumab. The drug is being developed by Precigen, Inc. for type 1 diabetes.