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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01809353 | To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants | PHASE1 | COMPLETED | 32 | — | — | Jul 1, 2013 | Sep 1, 2014 | Mar 23, 2015 | 1 | United States |
Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840
| Arm | Type | Description |
|---|---|---|
| Group A: JNJ-54452840 20 mg | EXPERIMENTAL | Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: JNJ-54452840 80 mg | EXPERIMENTAL | Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: JNJ-54452840 240 mg | EXPERIMENTAL | Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: Placebo | PLACEBO_COMPARATOR | Each participant will receive matching placebo as a single intravenous dose. |
| Group B: JNJ-54452840 20 mg | EXPERIMENTAL | Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: JNJ-54452840 80 mg | EXPERIMENTAL | Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: JNJ-54452840 240 mg | EXPERIMENTAL | Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: Placebo | PLACEBO_COMPARATOR | Each participant will receive matching placebo as a single intravenous dose. |
| Name | Type | Description |
|---|---|---|
| JNJ-54452840 | DRUG | Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg |
| Placebo | OTHER | Single matching intravenous dose |
Inclusion Criteria: * Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian * Japanese participants must have been born in Japan, have resided outs...