Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MTX-463 · 1 trial · 1 indication
Clinical Safety Labs are collected, and Adverse Events are assessed in both inpatient and outpatient clinic visits
Blood serum samples will be collected at protocol-specified timepoints throughout the study
Blood serum samples will be collected at protocol-specified timepoints throughout the study to assess for the presence and titer (if applicable) of Anti-Drug Antibodies.
Blood serum samples will be collected at protocol-specified timepoints throughout the study
Blood serum samples will be collected at protocol-specified timepoints throughout the study
Blood serum samples will be collected at protocol-specified timepoints throughout the study
| Arm | Type | Description |
|---|---|---|
| MTX-463 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MTX-463 | BIOLOGICAL | MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases and malignancies. |
| Placebo | OTHER | Matching Placebo-- Normal Saline |
Key Inclusion Criteria: * All genders, ages 18 to 60 years, inclusive * Willing and able to complete all protocol-required study visits and procedures * Non-smoker and has not used nicotine- or cotinine-containing products (including tobacco, nicotine gum, patches, and e-cigarettes) for at least 90...
MTX-463 is an investigational monoclonal antibody being developed by Icon Plc (ticker: ICLR). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its therapeutic area is classified as other. It is not yet approved and remains in clinical trials.
MTX-463 is being studied for use in healthy volunteers as part of a first-in-human safety trial. The drug is an investigational monoclonal antibody, and its intended therapeutic use has not been established. It is currently in Phase 1 clinical development, with no approved indications.
MTX-463 is being developed by Icon Plc, a company traded under the ticker ICLR. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development. Icon Plc is conducting a first-in-human safety trial of MTX-463 in healthy volunteers.
MTX-463 is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied in a first-in-human safety trial. The drug has not been approved and is still in clinical trials. One Phase 1 trial has been completed.
MTX-463 has one completed Phase 1 clinical trial, identified as NCT06401213, titled "A First-in-Human Safety Trial of MTX-463." This trial enrolled 56 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled. The trial is now completed.
No alternative names for MTX-463 have been reported. The drug is an investigational monoclonal antibody developed by Icon Plc and is identified by the name MTX-463 in clinical trials. It is currently in Phase 1 development for healthy volunteers.