Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INV21 Low Dose · 1 trial · 1 indication
Frequency and severity of systemic adverse events up to 56 days post first dose. Frequency and severity of local reactions up to 14 days post each dose.
| Arm | Type | Description |
|---|---|---|
| INV21 Low Dose | EXPERIMENTAL | - |
| INV21 High Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| INV21 Low Dose | BIOLOGICAL | Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide. |
| INV21 High Dose | BIOLOGICAL | Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide. |
| Placebo | BIOLOGICAL | Phosphate Buffered Saline (PBS) |
Inclusion Criteria: * Male or female aged 21 to 45 years, inclusive, at time of screening * In good health as determined by medical history and physical examination. * Normal clinical safety laboratory examinations. * Body mass index (BMI) in the range 19-28 kg/m2. * Documented negative serology fo...
INV21 Low Dose is an investigational monoclonal antibody being studied for the prevention of Hand, Foot and Mouth Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
INV21 Low Dose is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker symbol TAK.
INV21 Low Dose is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use.
INV21 Low Dose has been studied in one completed Phase 1 clinical trial, identified as NCT01376479. This trial evaluated the safety and immunogenicity of an inactivated vaccine against Hand, Foot and Mouth Disease caused by Enterovirus 71 in Singapore.
INV21 Low Dose is described as a monoclonal antibody, while the clinical trial NCT01376479 studied an inactivated vaccine against Hand, Foot and Mouth Disease. The relationship between these two entities is not specified.