NL-OMON50999CompletedNot Applicable
A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants. - Evaluation of safety,tolerability,PK and PD of subcutaneous Nipocalimab
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen-Cilag
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Healthy on the basis of physical examination, medical history, vital signs,
- •and 12-lead electrocardiogram (ECG) performed at screening
- •- Healthy on the basis of clinical laboratory tests performed at screening
- •- Continuous non-smoker
- •- A woman of childbearing potential must have a negative pregnancy test
- •- It is recommended that participants are up to date on all age appropriate
- •vaccinations prior to screening as per routine local medical guidelines
Exclusion Criteria
- •- Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary,
- •gastrointestinal, endocrine, neurologic, hematologic, rheumatologic,
- •psychiatric, or metabolic disturbances
- •- Currently has a malignancy or has a history of malignancy within 3 years
- •before screening
- •- Known allergies, hypersensitivity, or intolerance to nipocalimab or its
- •- Has received a live vaccine within 3 months prior to screening or has a known
- •need to receive a live vaccine during the study, or within at least 3 months
- •after the last administration of study intervention in this study
- •- Shows evidence of an active or chronic hepatitis B infection
Investigators
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