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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05541315 | A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants | PHASE1 | COMPLETED | 40 | — | — | Sep 14, 2022 | May 9, 2023 | Mar 30, 2025 | 1 | United States |
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) * ...