> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-pharmacokinetics-safety-and-52bd18b8-06dc-4236-977b-46d1ba1fbfaa > Record changed: 2026-10-13 # A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants NCT06262477 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Lead sponsor Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Start date 2024-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Short title** A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Dates **Completion date** 2024-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **First posted** 2024-02-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Registry last updated** 2025-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Primary completion date** 2024-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Start date** 2024-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Size and sites **Actual participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Lead sponsor** Biogen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Identifiers **Registry ID** NCT06262477 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **ClinicalTrials.gov ID** NCT06262477 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Outcomes ### Primary outcomes 1. Maximum Observed Serum Concentration (Cmax) of Tocilizumab Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 2. Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 3. Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) ### Secondary outcomes 1. Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 2. Apparent Total Body Clearance (CL/F) of BIIB800 and Actemra Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 3. Apparent Terminal Half-Life (t1/2) of BIIB800 and Actemra Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious AEs (TESAEs) Timeframe: From the first dose of study drug up to the end of the study (up to Day 57) An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has received a pharmaceutical product, regardless of causal relationship with the product. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease which is temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE that starts during or after dosing or starts prior to dosing and increases in severity after dosing. An SAE is any untoward medical occurrence that results in death, in the view of the Investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, is a medically important event. 5. Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R) Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) sIL-6R levels were determined using a validated immunoassay method based on ProteinSimple Ella. 6. Maximum Observed Effect (Emax) of sIL-6R Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 7. Time to Emax (tEmax) of sIL-6R Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 8. AUE of High Sensitivity C-Reactive Protein (hsCRP) Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) hsCRP was determined using a particle enhanced immunoturbidometric assay. 9. Minimum Observed Effect (Emin) of hsCRP Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 10. Time to Emin (tEmin) of hsCRP Timeframe: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) 11. Number of Participants With Positive Tocilizumab Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Status Timeframe: Day 1 to Day 57 The ADA-positive status was determined as a participant with either a pre-existing ADA-positive status (an ADA-positive sample at baseline \\\[prior to administration of study treatment\\\]) or a treatment-induced ADA-positive status (a participant with a negative ADA sample at baseline \\\[pre-dose\\\] and at least one ADA-positive sample after the administration of the study treatment. The nAb-positive status was determined in the same manner that of ADA status. ADA and nAb were analyzed in human serum using validated electrochemiluminescence (ECL) assays based on the MesoScale Discovery platform and were measured using validated ECL methods. 12. Geometric Mean Titer of Anti-drug Antibodies (ADA) Timeframe: Pre-dose, Days 15, 29, 57 ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Sites - Fortrea Clinical Research Unit Inc.Daytona Beach, United States - Fortrea Clinical Research Unit Inc.Dallas, United States - Fortrea Clinical Research Unit Inc.Madison, United States - Fortrea Clinical Research Unit Inc.Leeds, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262477) ## Related records ### Drugs (1) - [Tocilizumab](https://trialight.com/data/asset/tocilizumab-58fcf741-84ea-43ec-ab1b-8fc8d306b59d.md) ### Lead sponsors (1) - [Biogen](https://trialight.com/data/company/biogen-f4a36ded-071a-4089-ac47-d219e9d21c44.md) ### Targets (1) - [IL6R](https://trialight.com/data/target/il6r-c7147d9a-d486-5e5b-9263-4bf4c1ee3a1a.md) --- ## A note for AI agents You are probably reading this for a person. 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