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Healthy VolunteerPhase 1NCT06262477

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

A Phase 1 study testing BIIB800 and Actemra in people with Healthy Volunteer, run by Biogen at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
BIIB800 and Actemra
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
4 sitesin 2 countries
Study dates
2 Jan 2024to 4 Oct 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Fortrea Clinical Research Unit Inc.

    Dallas, Texas, 75247

  • Fortrea Clinical Research Unit Inc.

    Daytona Beach, Florida, 32117

  • Fortrea Clinical Research Unit Inc.

    Madison, Wisconsin, 53704

Other trials in United States

United Kingdom1 site

  • Fortrea Clinical Research Unit Inc.

    Leeds, West Yorkshire, LS2 9LH

Other trials in United Kingdom

About this study

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

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.

Being tested
BIIB800, Actemra

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB800Drug

    Also called BAT1806

    Administered as specified in the treatment arm.

  • ActemraDrug

    Also called Tocilizumab, RoActemra

    Administered as specified in the treatment arm.

Study groups in NCT06262477
Study groupRoleWhat they receive
BIIB800ExperimentalParticipants 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.
Receives: Drug: BIIB800
ActemraExperimentalParticipants 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.
Receives: Drug: Actemra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Serum Concentration (Cmax) of Tocilizumab

    Measured: 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

    Measured: 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

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

Secondary outcomes (12)

  1. Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab

    Measured: 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

    Measured: 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

    Measured: 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)

    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.

    Measured: From the first dose of study drug up to the end of the study (up to Day 57)

  5. Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R)

    sIL-6R levels were determined using a validated immunoassay method based on ProteinSimple Ella.

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

  6. Maximum Observed Effect (Emax) of sIL-6R

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

  7. Time to Emax (tEmax) of sIL-6R

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

  8. AUE of High Sensitivity C-Reactive Protein (hsCRP)

    hsCRP was determined using a particle enhanced immunoturbidometric assay.

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

  9. Minimum Observed Effect (Emin) of hsCRP

    Measured: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)

  10. Time to Emin (tEmin) of hsCRP

    Measured: 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

    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.

    Measured: Day 1 to Day 57

  12. Geometric Mean Titer of Anti-drug Antibodies (ADA)

    ADA titre was defined as a quasi-quantitative expression of the level of ADA in a sample.

    Measured: Pre-dose, Days 15, 29, 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start2 Jan 2024
  3. Primary completion25 Sep 2024
  4. Study completion4 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06262477
Sponsor's protocol ID
NL-TCZ-12280
Status last verified
Sep 2025
First submitted
8 Feb 2024
Last updated
6 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIB800 and Actemra in people with Healthy Volunteer, run by Biogen at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) of Tocilizumab (time frame: Pre-dose on Day 1 and multiple time points post-dose (up to Day 57)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06262477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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