A Study to Assess the Safety, Tolerability, Pharmacokinet... | NCT03080987

ID	Type	Description	Link
2016-004785-25	EudraCT Number
64179375EDI1002	Other Identifier	Janssen Research & Development, LLC

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: JNJ-64179375 0.3 mg/kg Other: Placebo
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.	Drug: JNJ-64179375 1.0 mg/kg Other: Placebo
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.	Drug: JNJ-64179375 2.5 mg/kg Other: Placebo
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.	Other: Placebo Drug: JNJ-64179375 (Dose to be Determined)
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64179375 0.3 mg/kg	Drug	JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.	Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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.	Up to Day 113
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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.	Up to Day 113

Secondary Outcomes

Measure	Description	Time Frame
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375	Cmax is the maximum observed plasma concentration.	Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375

Eligibility Module

Eligibility Criteria

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 health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
Clinically significant abnormal physical exam at Screening or Day -1
Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee

Facility	Status	City	State	ZIP	Country	Contacts
Souseikai Hakata Clinic		Fukuoka		812-0025	Japan
Hammersmith Medicines Research Ltd