Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M5542 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| M5542 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| M5542 | BIOLOGICAL | Participants will receive a single ascending dose of M5542 subcutaneously on Day 1. |
| Placebo | BIOLOGICAL | Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1. |
Inclusion Criteria: * Participants are overtly healthy, as determined by medical evaluation, by physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study eval...
M5542 is an investigational monoclonal antibody being developed by Merck KGaA. It is in Phase 1 clinical development and is being studied in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
M5542 is being developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. The company is running the Phase 1 program for this monoclonal antibody candidate.
M5542 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency and remains an investigational agent. One Phase 1 trial is currently recruiting participants.
M5542 is being studied in one Phase 1 trial, NCT06577337, titled a Phase 1 study of single ascending doses of M5542 in healthy participants. The trial is recruiting, is placebo controlled and double blind, and plans to enroll 49 participants in Germany.
The M5542 Phase 1 trial, NCT06577337, is a single ascending dose study in healthy adult volunteers aged 18 years and older. It is randomized, double blind, and placebo controlled, with a planned enrollment of 49 participants across sites in Germany.