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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen-Cilag
- 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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