A phase 1, open-label study to Investigate Drug-Drug Interaction (DDI) potential of Nipocalimab with coadministration of Etanercept or Hydroxychloroquine in healthy participants.
- Conditions
- Autoimmune- and inflammatory diseases10003816
- Registration Number
- NL-OMON49934
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
- 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
- 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 < 30 grams/Liter (g/L) at screening and Day -1
- Has a history of myocardial infarction, unstable ischemic heart disease, or
stroke within 12 weeks prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effect of nipocalimab on the PK of etanercept in healthy<br /><br>participants.<br /><br>To assess the effect of HCQ on total serum IgG reduction of or by nipocalimab<br /><br>in healthy participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of nipocalimab following coadministration<br /><br>of etanercept in healthy participants.<br /><br>To assess the PK of nipocalimab following coadministration of etanercept in<br /><br>healthy participants.<br /><br>To assess the immunogenicity of nipocalimab following coadministration of<br /><br>etanercept in healthy participants.<br /><br><br /><br>To assess and compare the PK of nipocalimab with and without coadministration<br /><br>of HCQ in healthy participants.<br /><br>To assess the effect of HCQ on nipocalimab PD in healthy participants</p><br>