The purpose of this study is to assess the safety and tolerability of JNJ-55920839 following single ascending intravenous (IV) dose administration in healthy participants and a single subcutaneous dose in healthy participants and multiple IV dose administrations in participants with mild to moderate Systemic Lupus Erythematosus (SLE).
This is a Phase 1, randomized, placebo-controlled, multicenter study of JNJ-55920839. The study consists of Screening Period of 28 days. The healthy participants will have a 6-day/5-night inpatient period. All Participants will receive study agent on Day 1 and SLE Participants will receive additional doses on Days 15, 29, 43, 57, and 71. The total duration of participation for each participant will be approximately 13 weeks for healthy participants, 22 weeks for participants with SLE. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of JNJ55920839 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion or as a subcutaneous injection. In Part 2, multiple doses of JNJ-55920839 or placebo will be administered as IV infusions to participants with SLE. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2, along with assessment of safety and clinical outcomes. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
0.9 percent (%) normal saline.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Durham, North Carolina, United States
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 1)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 13
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of JNJ-55920839 (Part 2)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 22
Maximum Observed Serum Concentration (Cmax) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration (Cmax) after SC injection in Part A
Time frame: Up to Day 64 after dose
Maximum Observed Serum Concentration during a dosing interval (Cmax) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Area under the serum concentration versus time curve from time 0 to the time corresponding to the last quantifiable serum concentration (AUC0-t) after SC injection in Part A
Time frame: Up to Day 64 after dose
Area under the serum concentration versus time curve between 2 defined sample points, t1 and t2 (AUCt1-t2) after IV infusion in Part B
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Unnamed facility
Leuven, Belgium
Unnamed facility
Merksem, Belgium
Unnamed facility
Chisinau, Moldova
Unnamed facility
Otwock, Poland
Unnamed facility
Szczecin, Poland
Unnamed facility
Bucharest, Romania
Unnamed facility
Timișoara, Romania
...and 6 more locations
Time frame: Up to Day 130 after dose
Terminal half-life (T1/2) after IV infusion in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after SC injection in Part A
Time frame: Up to Day 64 after dose
Terminal half-life (T1/2) after IV infusion in Part B
Time frame: Up to Day 130 after dose
Bioavailability (F) after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after SC injection in Part A
Time frame: Up to Day 64 after dose
Number of Participants With Antibodies to JNJ-55920839 after IV infusion in Part B
Time frame: Up to Day 130 after dose