The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
231
Vial supplied as a single-use preservative free solution for SC injection.
Autoinjector for SC injection.
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, United States
Maximum Plasma Concentration (Cmax) of Rocatinlimab
Time frame: Up to approximately 112 days
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Time frame: Up to approximately 112 days
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Time frame: Up to approximately 112 days
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Approximately 20 weeks
Number of Participants with Anti-rocatinlimab Antibodies
Time frame: Up to approximately Day 112
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