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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: BIIB800; Drug: Actemra

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • Fortrea Clinical Research Unit Inc.
• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit Inc.
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: BIIB800; Administered as specified in the treatment arm.; Other Names: BAT1806
Experimental: 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.	Drug: Actemra; Administered as specified in the treatment arm.; Other Names: RoActemra; Tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab		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)
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.	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.	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
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)
AUE of High Sensitivity C-Reactive Protein (hsCRP)	hsCRP was determined using a particle enhanced immunoturbidometric assay.	Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
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)
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.	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.	Pre-dose, Days 15, 29, 57

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tocilizumab
• Other Study ID Numbers: NL-TCZ-12280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No