Healthy men test new version of arthritis drug
NCT ID NCT06262477
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called BIIB800 against an approved drug, Actemra, in 300 healthy men. The goal was to see if the two drugs behave similarly in the body and are equally safe. Participants received a single injection and were monitored for side effects and drug levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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300 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
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Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fortrea Clinical Research Unit Inc.
Daytona Beach, Florida, 32117, United States
-
Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75247, United States
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Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704, United States
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Fortrea Clinical Research Unit Inc.
Leeds, West Yorkshire, LS2 9LH, United Kingdom
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