Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03550950 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | Jun 1, 2018 | Feb 5, 2019 | Feb 3, 2025 | 1 | Belgium |
An adverse event (AE) is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship. The severity of the TEAEs will be assessed as mild, moderate, or severe.
An 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.
Number of participants with clinically significant changes in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported.
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Number of participants with clinical laboratory abnormalities, including cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viral loads, will be reported.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) IV Cohort | EXPERIMENTAL | Participants will receive single intravenous (IV) dose of JNJ-64232025 or placebo in Cohorts 1 to 6 on Day 1. |
| Subcutaneous (SC) Cohort | EXPERIMENTAL | Participants will receive single dose of JNJ-64232025 or placebo as SC injection. |
| Name | Type | Description |
|---|---|---|
| JNJ-64232025 IV | DRUG | JNJ-64232025 will be administered as IV infusion. |
| JNJ-64232025 SC | DRUG | JNJ-64232025 will be administered as SC injection. |
| Placebo | DRUG | Matching placebo will be administered as IV infusion or SC injection. |
Inclusion Criteria: * Male or female of non-childbearing potential (postmenopausal or permanently sterile) * Have a body mass index (BMI) between 19 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), and a body weight of 50 to 100 kilogram (kg), inclusive * Healthy on the basis of...