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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262477
• Other study ID #: NL-TCZ-12280
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• BIIB800
Administered as specified in the treatment arm.
• Actemra
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Serum Concentration (Cmax) of Tocilizumab		Pre-dose and at multiple timepoints up to Day 57
Primary	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
Primary	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	Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab		Pre-dose and at multiple timepoints up to Day 57
Secondary	Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab		Pre-dose and at multiple timepoints up to Day 57
Secondary	Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab		Pre-dose and at multiple timepoints up to Day 57
Secondary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		From screening up to Day 57
Secondary	Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)		Pre-dose and at multiple timepoints up to Day 57
Secondary	Maximum Observed Effect (Emax) of sIL-6R		Pre-dose and at multiple timepoints up to Day 57
Secondary	Time to Emax (tEmax) of sIL-6R		Pre-dose and at multiple timepoints up to Day 57
Secondary	AUE of High Sensitive C-Reactive Protein (hsCRP)		Pre-dose and at multiple timepoints up to Day 57
Secondary	Minimum Observed Effect Emin of hsCRP		Pre-dose and at multiple timepoints up to Day 57
Secondary	Time to Emin (tEmin) of hsCRP		Pre-dose and at multiple timepoints up to Day 57
Secondary	Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs)		Pre-dose and at multiple timepoints up to Day 57
Secondary	Number of Participants With ADA Titers		Pre-dose and at multiple timepoints up to Day 57