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 therapeutic being developed by Exicure, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications being pursued for AST-008 have not been publicly disclosed.
AST-008 is being developed by Exicure, Inc., a biotechnology company that trades under the ticker symbol XCUR. Exicure is the sponsor responsible for advancing the AST-008 program through clinical development.
AST-008 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program for AST-008 has completed, with no active trials currently listed.
AST-008 has been evaluated in one clinical trial, NCT03086278, titled A Study of AST-008 in Healthy Subjects. This completed Phase 1 trial enrolled 16 healthy adult volunteers in the United Kingdom and was an uncontrolled study.
The Phase 1 trial of AST-008, NCT03086278, was an uncontrolled study conducted in the United Kingdom. It enrolled 16 healthy volunteers aged 18 years and older of all sexes. The trial was not randomized and not double blinded, and it has been completed.