The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Fortrea Clinical Research Unit Inc.
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, United States
Fortrea Clinical Research Unit Inc.
Leeds, West Yorkshire, United Kingdom
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Apparent Terminal Half-Life (t1/2) of BIIB800 and Actemra
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has received a pharmaceutical product, regardless of causal relationship with the product. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease which is temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE that starts during or after dosing or starts prior to dosing and increases in severity after dosing. An SAE is any untoward medical occurrence that results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, is a medically important event.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the first dose of study drug up to the end of the study (up to Day 57)
Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)
sIL-6R levels were determined using a validated immunoassay method based on ProteinSimple Ella.
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Maximum Observed Effect (Emax) of sIL-6R
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Emax (tEmax) of sIL-6R
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
AUE of High Sensitivity C-Reactive Protein (hsCRP)
hsCRP was determined using a particle enhanced immunoturbidometric assay.
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Minimum Observed Effect (Emin) of hsCRP
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Emin (tEmin) of hsCRP
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Number of Participants With Positive Tocilizumab Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Status
The ADA-positive status was determined as a participant with either a pre-existing ADA-positive status (an ADA-positive sample at baseline \[prior to administration of study treatment\]) or a treatment-induced ADA-positive status (a participant with a negative ADA sample at baseline \[pre-dose\] and at least one ADA-positive sample after the administration of the study treatment. The nAb-positive status was determined in the same manner that of ADA status. ADA and nAb were analyzed in human serum using validated electrochemiluminescence (ECL) assays based on the MesoScale Discovery platform and were measured using validated ECL methods.
Time frame: Day 1 to Day 57
Geometric Mean Titer of Anti-drug Antibodies (ADA)
ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample.
Time frame: Pre-dose, Days 15, 29, 57