Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MTX-474 · 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-474 | EXPERIMENTAL | Biological: MTX-474 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| MTX-474 | BIOLOGICAL | MTX-474 is an immunoglobin G1 (IgG1) monoclonal antibody directed against Ephrin B2 that binds to and has demonstrated ability to block phosphorylation of its preferred receptor EphB4. Increased levels of circulating soluble EphrinB2 have been found in patients with systemic sclerosis. |
| Placebo | OTHER | Matching Placebo - Normal Saline |
Inclusion Criteria: * All genders, ages 18 to 60 years, inclusive * Willing and able to complete all protocol-required study visits and procedures * Consumption of not more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, and e-cigarettes) per week ...
MTX-474 is an investigational monoclonal antibody being developed by cbdMD, Inc. (YCBD). 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 by regulatory authorities.
MTX-474 is being studied for use in healthy individuals as part of a first-in-human safety trial. The drug is in Phase 1 clinical development, and the completed trial enrolled healthy volunteers to assess safety. Its intended therapeutic use has not been established beyond this initial safety evaluation.
MTX-474 is a monoclonal antibody, a type of biologic drug designed to bind to specific targets in the body. However, the specific molecular target or target class for MTX-474 has not been disclosed. As a monoclonal antibody, it is expected to interact with a particular protein, but that target is not specified.
MTX-474 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical development of this investigational monoclonal antibody, which is currently in Phase 1 trials.
MTX-474 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a first-in-human safety study. This trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.
MTX-474 has been studied in one clinical trial, identified as NCT06535841, titled "A First-in-Human Safety Trial of MTX-474." This Phase 1 trial was completed and enrolled 78 healthy volunteers in Australia. The study was randomized, double-blind, and placebo-controlled, with a minimum age of 18 years.