A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: BIIB800
Drug: Actemra

Registration Number: NCT06262477

Lead Sponsor: Biogen

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 300

Inclusion Criteria

Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2), inclusive.
Total body weight between 60.0 and 90.0 kg, inclusive.
Systolic blood pressure <135 millimeters of mercury (mmHg) or >85 mmHg at Screening, after being supine for at least 5 minutes.
No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker.

Key

Exclusion Criteria

History or positive test result at Screening for human immunodeficiency virus (HIV).
History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody.
Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and total hepatitis B core antibody [anti-HBc]).
Serious infection (as determined by the Investigator) within the 6 months prior to Screening.
History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders.
History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions.
History of angioedema.
A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results.
Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.).
Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIIB800	BIIB800	Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
Actemra	Actemra	Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Maximum Observed Serum Concentration (Cmax) of Tocilizumab	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	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs)	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.
Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)	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.
Maximum Observed Effect (Emax) of sIL-6R	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Emax (tEmax) of sIL-6R	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	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	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
AUE of High Sensitivity C-Reactive Protein (hsCRP)	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)	hsCRP was determined using a particle enhanced immunoturbidometric assay.
Minimum Observed Effect (Emin) of hsCRP	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Emin (tEmin) of hsCRP	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab	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	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.
Geometric Mean Titer of Anti-drug Antibodies (ADA)	Pre-dose, Days 15, 29, 57	ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample.

Trial Locations

Locations (1): Fortrea Clinical Research Unit Inc.
🇬🇧
Leeds, West Yorkshire, United Kingdom
Fortrea Clinical Research Unit Inc.
🇬🇧Leeds, West Yorkshire, United Kingdom