Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRA023 Low Dose · 2 trials · 1 indication
Mean SC versus IV AUC(inf) values
Maximum concentration after single dose
Time to reach maximum concentration after single dose
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| PRA023 SC/Placebo IV | EXPERIMENTAL | Participants randomized to receive active subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV Low Dose | ACTIVE_COMPARATOR | Participants randomized to receive placebo subcutaneous injection/active intravenous infusion |
| Placebo SC/Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion |
| Placebo SC/PRA023 IV High Dose | EXPERIMENTAL | - |
| SAD Cohorts 1-6 Experimental Arm | EXPERIMENTAL | Subjects will receive single intravenous doses of PRA023 in a dose escalation format |
| SAD Cohorts 1-6 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive intravenous doses of placebo |
| MAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format |
| MAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Subjects will receive three intravenous doses of placebo, one dose every 2 weeks, |
| Name | Type | Description |
|---|---|---|
| PRA023 IV Low Dose | DRUG | Drug |
| PRA023 SC | DRUG | Drug |
| Placebo IV | DRUG | Placebo |
| Placebo SC | DRUG | Placebo |
| PRA023 IV High Dose | DRUG | Drug |
| PRA023 | DRUG | PRA023 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Subjects are required to meet the following criteria in order to be included in the study: 1. Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin. 2. Caucasian subjects must be of European or Latin American descent (i.e....
PRA023 Low Dose is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with studies focused on evaluating the drug in healthy participants. The drug is not approved for any medical condition and remains under investigation.
PRA023 Low Dose 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 early-stage clinical trials to evaluate the drug in healthy volunteers.
PRA023 Low Dose is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any use.
PRA023 Low Dose has been studied in two completed Phase 1 trials: NCT04676178, a study in healthy volunteers with 69 participants, and NCT05354349, a bioavailability and Japanese ethnobridging study with 49 participants. Both trials were conducted in the United States.
PRA023 Low Dose is a formulation or dosing variant of the investigational drug PRA023. The clinical trials listed for PRA023 Low Dose evaluate the drug in healthy volunteers, with one study specifically examining the bioavailability of a subcutaneous formulation.