Clinical trial NCT06262477: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Serum Concentration (Cmax) of Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
Secondary outcomes:
measure: Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From screening up to Day 57
measure: Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Maximum Observed Effect (Emax) of sIL-6R
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Time to Emax (tEmax) of sIL-6R
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: AUE of High Sensitive C-Reactive Protein (hsCRP)
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Minimum Observed Effect Emin of hsCRP
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Time to Emin (tEmin) of hsCRP
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs)
timeFrame: Pre-dose and at multiple timepoints up to Day 57
measure: Number of Participants With ADA Titers
timeFrame: Pre-dose and at multiple timepoints up to Day 57
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Florida
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Texas
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Wisconsin
city: Leeds
country: United Kingdom
facility: Fortrea Clinical Research Unit Inc.
state: West Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: