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Also known as JNJ-64232025 IV
JNJ-64232025 · 1 trial · 1 indication
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...
JNJ-64232025 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy participants to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. The specific disease indications for which it is being developed have not been disclosed.
JNJ-64232025 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company sponsored the Phase 1 study of the compound in healthy volunteers.
JNJ-64232025 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
JNJ-64232025 has been evaluated in a single Phase 1 trial, NCT03550950, titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants." The trial enrolled 48 healthy volunteers in Belgium and has been completed.
Yes, JNJ-64232025 IV is another name for JNJ-64232025. The "IV" designation refers to the intravenous formulation used in the Phase 1 study. Both names refer to the same investigational small molecule developed by Johnson & Johnson.