Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-88260237 · 1 trial · 1 indication
Number of participants with AEs will be reported.
Number of participants with AEs will be reported.
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Number of participants with abnormalities in physical examinations will be reported.
Number of participants with abnormalities in physical examinations will be reported.
| Arm | Type | Description |
|---|---|---|
| JNJ-88260237 | EXPERIMENTAL | Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization. |
| Placebo | PLACEBO_COMPARATOR | Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-88260237 | DRUG | JNJ-88260237 will be administered orally. |
| Placebo | DRUG | Matching placebo will be administered orally. |
Inclusion Criteria: * Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening * Body mass index (BMI) within the range 18 to 30 kilogram/meter\^2 (kg/m\^2) (inclusive) * ...
JNJ-88260237 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants, and its specific therapeutic indication has not been disclosed. It is not an approved medicine and remains in early clinical development.
JNJ-88260237 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound conducted in the United States.
JNJ-88260237 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
JNJ-88260237 has been evaluated in one clinical trial, NCT05541315, titled A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants. The Phase 1 study enrolled 40 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.
The Phase 1 trial NCT05541315 was a single ascending dose study of JNJ-88260237 in healthy participants. It enrolled 40 adults aged 25 years and older, was randomized, double-blind, and placebo-controlled, and was conducted in the United States. The study has been completed.