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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02758392 | A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants | PHASE1 | COMPLETED | 54 | — | — | Apr 1, 2016 | Jan 1, 2017 | Jan 23, 2017 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Dose 1: JNJ-61178104 OR Placebo IV | EXPERIMENTAL | Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1. |
| Dose 2: JNJ-61178104 OR Placebo IV | EXPERIMENTAL | Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1. |
| Dose 3: JNJ-61178104 OR Placebo IV | EXPERIMENTAL | Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1. |
| Dose 4: JNJ-61178104 OR Placebo IV | EXPERIMENTAL | Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1. |
| Dose 5: JNJ-61178104 OR Placebo IV | EXPERIMENTAL | Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1. |
| Dose 6: JNJ-61178104 OR Placebo SC | EXPERIMENTAL | Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-61178104 Intravenous | DRUG | Participants will receive JNJ-61178104 Intravenously on Day 1. |
| JNJ-61178104 Subcutaneous | DRUG | Participants will receive JNJ-61178104 Subcutaneously on Day 1. |
| Placebo | DRUG | Participants will receive placebo on Day 1. |
Inclusion Criteria * Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study * Participant must have a body weight in the range of 50 Kilogram (kg) to 100 kg, inclusiv...