drugset / Trial / NCT02949206
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function (Part 2) in healthy male participants.
Timeline
- Start
- 2016-11-14
- Primary completion
- 2017-08-09
- Completion
- 2017-08-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 4 Factor Prothrombin Complex Concentrate (PCC) | Unknown | 50 iu/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 0.03 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 2.5 mg/kg | Intravenous |
| Subject | ICHORCUMAB | Monoclonal antibody | 5 mg/kg | Intravenous |
Indications
No indication recorded.