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.

Completed

Conditions: Autoimmune- and inflammatory diseases
10003816

Registration Number: NL-OMON50999

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of single and multiple doses of<br /><br>nipocalimab following SC administration compared with IV administration in<br /><br>healthy participants.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the PK of single and multiple doses of nipocalimab following SC<br /><br>administration compared with IV administration in healthy participants.<br /><br><br /><br>To evaluate the PD effect of nipocalimab on IgG following SC administration<br /><br>compared with IV administration in healthy participants.<br /><br><br /><br>To evaluate the antidrug antibody response of nipocalimab following SC<br /><br>administration compared with IV administration in healthy participants.</p><br>