The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Vial solution for SC injection administered on Day 1
Prefilled syringe solution for SC injection administered on Day 1
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
Fortrea Clinical Research Unit Limited - Leeds
Leeds, LDS, United Kingdom
Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
Time frame: Up to Day 112
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Time frame: Up to Day 112
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Time frame: Up to Day 112
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Up to approximately 20 weeks
Number of Participants Experiencing Serious Adverse Events (SAE)
A SAE is defined as any adverse event (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: Up to approximately 20 weeks
Number of Participants Positive to Anti-rocatinlimab Antibody
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 112