A Study of Nipocalimab in Healthy Male and Female Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: Nipocalimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04848558

80202135EDI1001 (Other Identifier)

CR108993

2020-005892-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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89 participants in 2 patient groups

Part 1: Single Dose Cohorts

Experimental group

Description:

Participants will receive subcutaneous (SC) injection or intravenous (IV) infusion of nipocalimab or placebo in single ascending doses on Day 1 in Cohorts 1-6 and SC administration in optional Cohorts 7-8.

Treatment:

Other: Placebo

Drug: Nipocalimab

Part 2: Multiple Dose Cohorts

Experimental group

Description:

Participants will receive up to 4 weekly SC injections of nipocalimab or placebo on Days 1, 8, 15, and 22 in Cohort 1 or 4 biweekly SC injections on Days 1, 15, 29, and 43 in optional Cohort 2.

Treatment:

Other: Placebo

Drug: Nipocalimab