NL-OMON49934
Completed
N/A
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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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