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 developed by Precigen, Inc. for type 1 diabetes. It is a low-dose formulation of AG019 that was studied in a Phase 1 clinical trial in participants with recently diagnosed type 1 diabetes, both alone and in combination with teplizumab.
AG019 - Low Dose was studied for use in type 1 diabetes, specifically in participants with recent-onset diagnosed type 1 diabetes. The Phase 1 trial evaluated the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in this patient population.
AG019 - Low Dose is developed by Precigen, Inc., which trades on the Nasdaq under the ticker symbol PGEN. Precigen sponsored the Phase 1 clinical trial of AG019 - Low Dose in type 1 diabetes.
AG019 - Low Dose is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single Phase 1 trial of AG019 - Low Dose has been completed, and no active trials of this agent are currently listed.
AG019 - Low Dose was evaluated in one completed Phase 1 trial, NCT03751007, titled a study to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset diagnosed type 1 diabetes. The trial enrolled 45 participants across the United States and Belgium.
AG019 - Low Dose is the low-dose form of AG019, and the name is also written as AG019 - Low Dose. It refers to the same investigational monoclonal antibody developed by Precigen, Inc. for type 1 diabetes, studied in the completed Phase 1 trial NCT03751007.