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JNJ-64179375 · 2 trials · 1 indication
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...
JNJ-64179375 is an investigational small molecule being studied for venous thromboembolism (VTE) prophylaxis with anticoagulation after total knee replacement surgery. It is also being evaluated in healthy volunteers to assess its safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics.
JNJ-64179375 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in clinical development and has not been approved by regulatory authorities.
JNJ-64179375 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials evaluated safety and tolerability in healthy subjects, while the Phase 2 trial compared the drug to apixaban in patients undergoing total knee replacement surgery. It remains investigational.
JNJ-64179375 has been studied in three completed trials: NCT02949206 and NCT03080987, both Phase 1 studies in healthy volunteers, and NCT03251482, a Phase 2 study in patients undergoing elective total knee replacement surgery comparing the drug to oral apixaban.
No, JNJ-64179375 is not the same as apixaban. In a Phase 2 clinical trial, intravenous JNJ-64179375 was compared against oral apixaban in participants undergoing elective total knee replacement surgery. The two drugs are distinct investigational and approved anticoagulants, respectively.