| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04544826 | A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses | PHASE1 | COMPLETED | 24 | — | — | Oct 16, 2020 | Aug 5, 2021 | Sep 29, 2021 | 1 | Australia |
| NCT04544813 | A Study of JNJ-77474462 in Healthy Participants | PHASE1 | COMPLETED | 78 | — | — | Oct 13, 2020 | May 30, 2021 | Jun 29, 2023 | 1 | Australia |
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...