A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
- 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 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 Maximum Serum Concentration (Cmax) of Tocilizumab Pre-dose and at multiple timepoints up to Day 57
- Secondary Outcome Measures
Name Time Method Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab 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 Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab 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 Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab 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 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 Minimum Observed Effect Emin 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
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc.
🇬🇧Leeds, West Yorkshire, United Kingdom