Approval Probability
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Adjusted LOA
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MDX2301 · 1 trial · 2 indications
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.
| Arm | Type | Description |
|---|---|---|
| Single Dose Healthy Adults MDX2301 | EXPERIMENTAL | Healthy Adults will receive a single dose of MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection. |
| Single Dose Healthy Adults Placebo | PLACEBO_COMPARATOR | Healthy Adults will receive a single dose of placebo as intravenous infusion, intramuscular injection, or subcutaneous injection. |
| Repeat Dose Healthy Adults MDX2301 | EXPERIMENTAL | Healthy Adults will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection and then receive a repeat dose of MDX2301, 3 months later as intramuscular injection or subcutaneous injection. |
| Repeat Dose Healthy Adults Placebo | PLACEBO_COMPARATOR | Healthy Adults will receive a single dose of placebo as intramuscular injection or subcutaneous injection and then receive a repeat dose of placebo 3 months later as intramuscular injection or subcutaneous injection. |
| Single-Dose Higher Risk Adults MDX2301 | EXPERIMENTAL | Adults at higher risk for severe COVID-19 will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection. |
| Single-Dose Higher Risk Adults Placebo | PLACEBO_COMPARATOR | Adults at higher risk for severe COVID-19 will receive a single dose of placebo as intramuscular injection or subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| MDX2301 | BIOLOGICAL | MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection. |
| Normal Saline | BIOLOGICAL | Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection. |
Inclusion Criteria Healthy Adults 1. Participant is a healthy male or female, 18 to 64 years of age. 2. Participant is in good health in the opinion of the investigator. Adults at Higher Risk for Developing Severe COVID-19: 3. Participant is a male or female, 18 to 64 years of age. 4. Particip...
MDX2301 is an investigational monoclonal antibody being developed for the prevention of COVID-19. It is currently being evaluated in a Phase 1 clinical trial in healthy adults and adults at higher risk for severe COVID-19. The drug is designed to target SARS-CoV-2, the virus that causes COVID-19.
MDX2301 targets SARS-CoV-2, the virus responsible for COVID-19. As a monoclonal antibody, it is designed to bind to the virus, potentially neutralizing it and preventing infection. The drug is being studied for its ability to prevent COVID-19 in healthy adults and those at higher risk for severe disease.
MDX2301 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The company is currently conducting a Phase 1 clinical trial to evaluate the safety and efficacy of MDX2301 in preventing COVID-19.
MDX2301 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy adults and those at higher risk for severe COVID-19.
MDX2301 is being studied in a Phase 1 clinical trial with the identifier NCT07445971. This randomized, double-blind, placebo-controlled trial is recruiting 80 participants in the United States. The study is evaluating MDX2301 in healthy adults and adults at higher risk for severe COVID-19, with a focus on prevention.
MDX2301 is a unique investigational monoclonal antibody developed by Opko Health Inc. There are no alternative names provided for this drug. It is currently in Phase 1 clinical trials for the prevention of COVID-19 and is not yet approved for any use.