Autoimmune- and inflammatory diseases
Conditions
Interventions
Day 1 etanercept 50 mg subcutaneous injection once
Day 29 nipocalimab 15 mg/kg once intravenous infusion
Day 43 nipocalimab 15 mg/kg intravenous infusion once and etanercept 50 mg
subcutaneous inject
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator - Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin [Ig]G) and at admission to the study site. If the results of the serum chemistry panel, liver panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator - Good venous access in both arms - Participants must have heart rate of at least 50 beats per minute - Participant is considered eligible according to the following tuberculosis (TB) screening criteria (for Part 1 only): a) have no history of latent or active TB before screening; b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) have had no recent close contact with a person with active TB; d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention
Exclusion criteria
Exclusion criteria: - Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has a history of retinal and macular disease (only for Part 2) - Has shown a previous severe immediate hypersensitivity reaction response, including anaphylaxis, to therapeutic proteins (example, monoclonal antibody [mAbs]) - Has serum albumin levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of nipocalimab on the PK of etanercept in healthy participants. To assess the effect of HCQ on total serum IgG reduction of or by nipocalimab in healthy participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of nipocalimab following coadministration of etanercept in healthy participants. To assess the PK of nipocalimab following coadministration of etanercept in healthy participants. To assess the immunogenicity of nipocalimab following coadministration of etanercept in healthy participants. To assess and compare the PK of nipocalimab with and without coadministration of HCQ in healthy participants. To assess the effect of HCQ on nipocalimab PD in healthy participants | — |
Countries
Netherlands
Outcome results
None listed