NCT06262477CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
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.
Arms & Interventions
BIIB800
Experimental
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.
Intervention: BIIB800 (Drug)
Actemra
Experimental
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.
Intervention: Actemra (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
Time Frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
Time Frame: 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
Time Frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)
Secondary Outcomes
- 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))
- 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))
- 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))
- 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)
- Geometric Mean Titer of Anti-drug Antibodies (ADA)(Pre-dose, Days 15, 29, 57)
Investigators
Study Sites (1)
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