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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03080987 | A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants | PHASE1 | COMPLETED | 40 | — | — | Jun 27, 2017 | Jun 25, 2018 | Feb 3, 2025 | 2 | Japan, United Kingdom |
| NCT02949206 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects | PHASE1 | COMPLETED | 80 | — | — | Nov 14, 2016 | Aug 9, 2017 | Sep 25, 2017 | 1 | Belgium |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Change in Potential for Reversibility of the JNJ-64179375 will be assessed by assessing the change in thrombin time as coagulation parameter.
Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)100.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. |
| Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. |
| Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Cohort 1 (0.03 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 0.03 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 2 (0.1 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 0.1 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 3 (0.3 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 0.3 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 4 (1.0 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 5 (2.5 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 6 (5.0 mg/kg of JNJ-64179375 or Placebo) | EXPERIMENTAL | Participants in a ratio of 3:1 will receive a single 5.0 mg/kg IV dose of JNJ-64179375 or matching placebo on Day 1. |
| Part 1: Cohort 7 (Escalation Dose of JNJ-64179375 or Placebo) | EXPERIMENTAL | Dose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached. |
| Part 1: Cohort 8 (Escalation Dose of JNJ-64179375 or Placebo) | EXPERIMENTAL | Dose escalation will proceed until the toxicology study exposure limits or a highest tolerable dose will be reached. |
| Part 2: Reversal Cohort :(50 IU/kg of 4-factor PCC) | EXPERIMENTAL | Participants will receive a 2.5 mg/kg of JNJ-64179375 or highest tolerable dose if lower than 2.5 mg/kg followed by administration of a single IV 50 International Unit per kilogram (IU/Kg) dose of a 4 factor prothrombin complex concentrate (PCC) or matching placebo on Day 1. |
| Part 3: Subcutaneous Cohort (1.0 mg/kg of JNJ-64179375) | EXPERIMENTAL | Participants will receive a Single Subcutaneous (SC) dose of 1.0 mg.kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-64179375 0.3 mg/kg | DRUG | JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1. |
| JNJ-64179375 1.0 mg/kg | DRUG | JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2). |
| JNJ-64179375 2.5 mg/kg | DRUG | JNJ-64179375 2.5 mg/kg IV infusion on Day 1. |
| Placebo | OTHER | Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2). |
| JNJ-64179375 (Dose to be Determined) | DRUG | JNJ-64179375 IV infusion (Dose to be determined). |
| JNJ-64179375 | DRUG | During part 1, participants will receive a single ascending Intravenous dose of JNJ-64179375 ranging from (0.03 mg/kg to 5.0 mg/kg). In Part 2, participants will receive a 2.5 mg/kg or highest tolerable dose if lower than 2.5 mg/kg of JNJ-64179375. In Part 3, participants will receive a Single Subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375. |
| 4 Factor Prothrombin Complex Concentrate (PCC) | DRUG | Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC. |
Inclusion Criteria: * Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents * Body mass index (weight kg/m\^2) between 18 and 27 kilogram per square meter (kg/m\^2) (inclusive), and body weight greater than 50 kg but less than 100 kg * Generally in good he...