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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50999

Enrollment

Registered

2021-04-21

Start date

2021-05-25

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune- and inflammatory diseases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single and multiple doses of nipocalimab following SC administration compared with IV administration in healthy participants.	—

Secondary

Measure	Time frame
To evaluate the PK of single and multiple doses of nipocalimab following SC administration compared with IV administration in healthy participants. To evaluate the PD effect of nipocalimab on IgG following SC administration compared with IV administration in healthy participants. To evaluate the antidrug antibody response of nipocalimab following SC administration compared with IV administration in healthy participants.	—

Measure

Time frame

To evaluate the PK of single and multiple doses of nipocalimab following SC administration compared with IV administration in healthy participants. To evaluate the PD effect of nipocalimab on IgG following SC administration compared with IV administration in healthy participants. To evaluate the antidrug antibody response of nipocalimab following SC administration compared with IV administration in healthy participants.

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Countries

Netherlands

Outcome results