Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRA052 · 1 trial · 1 indication
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | EXPERIMENTAL | Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format |
| SAD Cohorts 1-8 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive a single intravenous or subcutaneous dose of placebo |
| MAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks |
| Name | Type | Description |
|---|---|---|
| PRA052 | DRUG | PRA052 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 60 years of age. * Male subjects must use reliable forms of contraception during sexual intercourse with female partners ...
PRA052 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability in healthy adults. PRA052 is not approved for any indication and remains in early-stage clinical research.
PRA052 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this investigational small molecule in healthy volunteers.
PRA052 is in Phase 1 clinical development. A Phase 1 study in healthy volunteers has been completed, with 96 participants enrolled. The drug is investigational and has not been approved by regulatory authorities for any use.
PRA052 has one completed Phase 1 clinical trial, registered as NCT05603182, titled "A Study of PRA052 in Healthy Volunteers." The trial was conducted in the United States, enrolled 96 healthy adults aged 18 years and older, and was randomized, double-blind, and placebo-controlled.
PRA052 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A single Phase 1 study in healthy volunteers has been completed, but the drug has not received marketing approval from the FDA or any other regulatory agency.