A Study to Assess the Safety, Tolerability and Pharmacoki... | NCT03536325

ID	Type	Description	Link
CNTO1959CRD1002	Other Identifier	Janssen Pharmaceutical K.K., Japan

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Guselkumab Dose 1 or Placebo	Experimental	Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.	Drug: Guselkumab Dose 1 Drug: Placebo
Cohort 2: Guselkumab Dose 2 or Placebo	Experimental	Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.	Drug: Guselkumab Dose 2 Drug: Placebo
Cohort 3: Guselkumab Dose 3 or Placebo	Experimental	Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.	Drug: Guselkumab Dose 3 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab Dose 1	Drug	Participants will receive Dose 1 of guselkumab on Day 1.	Cohort 1: Guselkumab Dose 1 or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE 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 approximately 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Serum Concentration (Cmax)	The Cmax is the maximum observed serum concentration.	Day 1: predose, end of infusion (EOI) and 8 hours (h) post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study, if the inpatient site allows. However, if smoking is not allowed in the inpatient site, smokers will not be allowed to smoke while inpatient cannot use nicotine replacement products during the inpatient period, but may smoke at other times during the study, up to the maximum stated above
Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol per day for the duration of 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, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Any medical contraindications preventing study participation