The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants.
This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Participants will receive JNJ-61178104 Intravenously on Day 1.
Participants will receive JNJ-61178104 Subcutaneously on Day 1.
Participants will receive placebo on Day 1.
Unnamed facility
Merksem, Belgium
Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
Time frame: Day 113
Serum Concentration of JNJ-61178104
Time frame: Up to Day 113
JNJ-61178104 Antibodies Concentration
Time frame: Up to Day 113
Cytokine Concentrations
Time frame: Predose, Up to Day 113
Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration
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Time frame: Up to Day 113
Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration
Time frame: Up to Day 113
Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration
The F is the percentage of the subcutaneously administered dose that is systemically available relative to an intravenous (IV) administration. It is calculated as (AUC \[0-infinity\] for 1 mg/kg SC JNJ-61178104)/(AUC \[0-infinity\] for 1 mg/kg IV JNJ-61178104 )\*100, where the AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time.
Time frame: Up to Day 113