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 being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development, studied in healthy participants. The drug is not approved and remains under clinical investigation.
JNJ-88260237 is being studied in healthy participants as part of early clinical development. Its intended therapeutic use has not been established, as it is in Phase 1 trials. The current study focuses on safety and tolerability in healthy volunteers.
JNJ-88260237 is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate this investigational small molecule.
JNJ-88260237 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet reported.
JNJ-88260237 has one completed Phase 1 trial, NCT05541315, titled 'A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants.' This randomized, double-blind, placebo-controlled study enrolled 40 healthy adults in the United States.
JNJ-88260237 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The completed trial in healthy participants is part of early-stage research to assess safety and tolerability.