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Clinical Trials/NL-OMON49934
NL-OMON49934CompletedNot Applicable

A phase 1, open-label study to Investigate Drug-Drug Interaction (DDI) potential of Nipocalimab with coadministration of Etanercept or Hydroxychloroquine in healthy participants. - DDI of Nipocalimab with Etanercept and HCQ.

Janssen-Cilag0 sites48 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

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

  • - 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
  • - 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

Investigators

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