A Study of Nipocalimab in Healthy Male and Female Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Single Dose Cohorts

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.

Group Type EXPERIMENTAL

Nipocalimab

Intervention Type DRUG

Participants will receive IV infusion or SC injection of nipocalimab.

Placebo

Intervention Type OTHER

Participants will receive IV infusion or SC injection of placebo.

Part 2: Multiple Dose Cohorts

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.

Group Type EXPERIMENTAL

Nipocalimab

Intervention Type DRUG

Participants will receive IV infusion or SC injection of nipocalimab.

Placebo

Intervention Type OTHER

Participants will receive IV infusion or SC injection of placebo.

Interventions

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Nipocalimab

Participants will receive IV infusion or SC injection of nipocalimab.

Intervention Type DRUG

Placebo

Participants will receive IV infusion or SC injection of placebo.

Intervention Type OTHER

Other Intervention Names

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JNJ-80202135

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes