Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AST-008 · 1 trial · 1 indication
To evaluate SAEs after a single subcutaneous dose of AST-008
To evaluate adverse events after a single subcutaneous dose of AST-008
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AST-008 | DRUG | AST-008 is a toll-like receptor 9 agonist. |
Main Inclusion Criteria: 1. Healthy male or female subjects aged ≥18 and ≤40 years of age at the time of first dosing. 2. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive. 3. Satisfactory medical assessment with no clinically significant or relevant abnormalities as dete...
AST-008 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial assessed its safety and tolerability in healthy subjects, with no therapeutic indication specified.
AST-008 is being developed by Exicure, Inc., a biopharmaceutical company. The company's stock trades under the ticker XCUR. The drug is in Phase 1 clinical development.
AST-008 is in Phase 1 clinical development. A Phase 1 study in healthy subjects has been completed. The drug is investigational and has not been approved by regulatory authorities.
AST-008 has one completed clinical trial, NCT03086278, titled "A Study of AST-008 in Healthy Subjects." This Phase 1 study enrolled 16 healthy volunteers in the United Kingdom and was not randomized or blinded.
AST-008 is not FDA approved. It is an investigational drug that has completed a Phase 1 study in healthy volunteers. No approval status has been granted, and it remains in clinical development.