Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-77474462 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.
Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count \[RBS\], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.
Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
Cmax is the maximum observed plasma concentration.
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: JNJ-77474462 (Low Dose) or Placebo | EXPERIMENTAL | Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection. |
| Cohort 2: JNJ-77474462 (Medium Dose) or Placebo | EXPERIMENTAL | Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection. |
| Cohort 3: JNJ-77474462 (High Dose) or Placebo | EXPERIMENTAL | Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection. |
| Cohort A: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 subcutaneously (SC). |
| Cohort B: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort C: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort D: JNJ-77474462 SC (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort E: JNJ-77474462 IV (Wave 1) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 intravenously (IV). |
| Cohort F: JNJ-77474462 SC (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort G: JNJ-77474462 SC (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 SC. |
| Cohort H: JNJ-77474462 IV (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 IV. |
| Cohort I: JNJ-77474462 IV (Wave 2) | EXPERIMENTAL | Participants will receive single dose of JNJ-77474462 IV. |
| Cohort J: Anakinra SC | ACTIVE_COMPARATOR | Participants will receive a SC injection of anakinra once daily for 3 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-77474462 | DRUG | JNJ-77474462 will be administered as SC injection. |
| Placebo | DRUG | Matching placebo to JNJ-77474462 will be administered as SC injection. |
| Anakinra | DRUG | Participants will receive a SC injection of anakinra 100 mg once daily for 3 days. |
Inclusion Criteria: * Participant must be of first to third generation Japanese descent * Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. Any abnormalities, must be consid...
JNJ-77474462 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development, studied in healthy participants. Two Phase 1 trials have been completed, with a total enrollment of 102 participants.
JNJ-77474462 is being studied in healthy participants, including those of Japanese descent, to evaluate its safety, tolerability, and pharmacokinetics. It is not approved for any disease and remains in early clinical development.
JNJ-77474462 is developed by Johnson & Johnson, a pharmaceutical company traded on the NYSE under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.
JNJ-77474462 is in Phase 1 clinical development. Two Phase 1 studies have been completed, both in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
JNJ-77474462 has two completed Phase 1 trials: NCT04544813, a study in healthy participants with 78 enrolled, and NCT04544826, a study in healthy participants of Japanese descent with 24 enrolled. Both were conducted in Australia.
Yes, JNJ-77474462 is also known as bermekimab. One of its Phase 1 trials, NCT04544826, explicitly refers to JNJ-77474462 as bermekimab, confirming the two names refer to the same investigational drug.