BIIB800
DrugAdministered as specified in the treatment arm.
Other names: BAT1806
NCT Number: NCT06262477
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.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Fortrea Clinical Research Unit Inc., Leeds, West Yorkshire, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered as specified in the treatment arm.
Other names: BAT1806
Administered as specified in the treatment arm.
Other names: Tocilizumab, RoActemra
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: From the first dose of study drug up to the end of the study (up to Day 57)
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.
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
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)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
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)
Time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time frame: Day 1 to Day 57
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: Pre-dose, Days 15, 29, 57
ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample.
Biogen
Industry
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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