Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07445971 | A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19. | PHASE1 | RECRUITING | 80 | — | — | Mar 1, 2026 | Dec 1, 2027 | Mar 4, 2026 | 2 | United States |
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...