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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
89
Participants will receive IV infusion or SC injection of nipocalimab.
Participants will receive IV infusion or SC injection of placebo.
PRA Health Sciences
Groningen, Netherlands
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to Day 85
Percentage of Participants with Serious Adverse Event (SAE)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Up to Day 85
Percentage of Participants with Reasonably Related AEs
Percentage of participants with reasonably related AEs will be reported. Reasonably related AE is an AE that has a casual relationship with the pharmaceutical/biological agent under study.
Time frame: Up to Day 85
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Percentage of participants with AEs leading to discontinuation of study intervention will be reported. The participants were discontinued from the study by the investigator if the safety reasons or tolerability reasons such as an AE, it is in the best interest of the participant to discontinue study intervention.
Time frame: Up to Day 85
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI; a) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; b) hypoalbuminemia with albumin less than (\<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Time frame: Up to Day 85
Number of Participants with Vital Signs Abnormalities
Number of participants with vital signs abnormalities including body temperature, pulse/heart rate, respiratory rate, blood pressure will be reported.
Time frame: Up to Day 85
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with ECG abnormalities will be reported.
Time frame: Up to Day 85
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities related to hematology, serum chemistry and urinalysis will be reported.
Time frame: Up to Day 85
Number of Participants with Subcutaneous (SC) Injection-site Reactions
Number of participants with SC injection-site reactions will be reported. An injection-site reaction is any AE at a SC study intervention injection-site.
Time frame: Up to Day 85
Serum Concentration of Nipocalimab
Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.
Time frame: Up to Day 85
Change from Baseline in Immunoglobulin (Ig) Levels Over Time
Change from baseline in Ig levels over time will be reported.
Time frame: Baseline to Day 85
Number of Participants with Antibodies to Nipocalimab
Number of participants with anti-drug antibodies to nipocalimab will be reported.
Time frame: Up to Day 85