A Study of Nipocalimab in Healthy Male and Female Participants

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

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.

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 excipients
• 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