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

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

Contacts and Locations

• Study Contact: Name: US Biogen Clinical Trial Center; Phone Number: 866-633-4636; Email: clinicaltrials@biogen.com
• Study Contact Backup: Name: Global Biogen Clinical Trial Center; Email: clinicaltrials@biogen.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortrea Clinical Research Unit Inc.
      • Contact: Phone Number: 608-210-5574; Email: sarah.russell@fortrea.com
      • Principal Investigator: Sarah Russell, MD

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 Serum Concentration (Cmax) of Tocilizumab	Pre-dose and at multiple timepoints up to Day 57
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab	Pre-dose and at multiple timepoints up to Day 57
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab	Pre-dose and at multiple timepoints up to Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab	Pre-dose and at multiple timepoints up to Day 57
Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab	Pre-dose and at multiple timepoints up to Day 57
Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab	Pre-dose and at multiple timepoints up to Day 57
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From screening up to Day 57
Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)	Pre-dose and at multiple timepoints up to Day 57
Maximum Observed Effect (Emax) of sIL-6R	Pre-dose and at multiple timepoints up to Day 57
Time to Emax (tEmax) of sIL-6R	Pre-dose and at multiple timepoints up to Day 57
AUE of High Sensitive C-Reactive Protein (hsCRP)	Pre-dose and at multiple timepoints up to Day 57
Minimum Observed Effect Emin of hsCRP	Pre-dose and at multiple timepoints up to Day 57
Time to Emin (tEmin) of hsCRP	Pre-dose and at multiple timepoints up to Day 57
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs)	Pre-dose and at multiple timepoints up to Day 57
Number of Participants With ADA Titers	Pre-dose and at multiple timepoints up to Day 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 (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 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 (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• 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