Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PRA023 IV Low Dose, PRA023
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 a low-dose small molecule formulation of PRA023, an investigational drug developed by Merck & Company, Inc. (MRK). It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific therapeutic indication for PRA023 Low Dose has not been publicly disclosed.
PRA023 Low Dose is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical studies evaluating this low-dose formulation of PRA023.
PRA023 Low Dose is in Phase 1 clinical development. Both of its completed trials were Phase 1 studies conducted in healthy volunteers. It is an investigational drug and has not been approved by the FDA for any indication.
PRA023 Low Dose has been evaluated in two completed Phase 1 trials: NCT05354349, a bioavailability and Japanese ethnobridging study of the subcutaneous formulation with 49 healthy participants, and NCT04676178, a study of PRA023 in 69 healthy volunteers. Both were randomized, double-blind, and placebo-controlled.
Yes. PRA023 Low Dose is a low-dose version of PRA023, also referred to as PRA023 IV Low Dose. The naming reflects the dose level of the same investigational compound rather than a separate drug asset.
The two completed Phase 1 trials of PRA023 Low Dose enrolled a combined total of 118 participants. NCT05354349 enrolled 49 healthy volunteers, and NCT04676178 enrolled 69 healthy volunteers. Both studies were conducted in the United States with participants aged 18 years and older.