Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64281802 · 1 trial · 1 indication
Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.
Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.
t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.
AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.
AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.
CL/F is defined as total apparent oral clearance of JNJ-64281802.
| Arm | Type | Description |
|---|---|---|
| Arm A: Panel 1 (JNJ-64281802 High Dose Regimen) | EXPERIMENTAL | Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. |
| Arm A: Panel 2 (JNJ-64281802 High Dose Regimen) | EXPERIMENTAL | Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27. |
| Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen) | EXPERIMENTAL | Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. |
| Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen) | EXPERIMENTAL | Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27. |
| Arm C: Panel 5 (JNJ-64281802 [Optional]) | EXPERIMENTAL | Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
| Arm C: Panel 6 (JNJ-64281802 [Optional]) | EXPERIMENTAL | Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
| Name | Type | Description |
|---|---|---|
| JNJ-64281802 | DRUG | JNJ-64281802 tablets will be administered orally as per the defined regimens. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant ...
JNJ-64281802 is an investigational small molecule drug developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed.
JNJ-64281802 is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company sponsored the Phase 1 study of the drug in healthy volunteers.
JNJ-64281802 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
JNJ-64281802 has been evaluated in one completed Phase 1 trial, NCT05201937, titled A Study of JNJ-64281802 in Healthy Adult Participants. The trial enrolled 33 healthy adults in the Netherlands and was controlled, though it was not randomized or double blinded.
No, JNJ-64281802 is not FDA approved. It is an investigational drug that has completed a single Phase 1 clinical trial in healthy volunteers. Further clinical development would be required before any regulatory approval could be considered.