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Healthy men help compare new drug to enbrel

NCT ID NCT06392074

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new biosimilar drug (MB04) against two versions of Enbrel in 141 healthy men. The goal was to see how the drugs move through the body and if they cause side effects or immune reactions. Participants received a single dose and had blood samples taken over several days to measure drug levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

141 people

The number who actually took part.

Started

Mar 2024

Finished

May 2025

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

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Inclusion Criteria 1. BMI: 18.5 kg/m2 to 29.9 kg/m2, inclusive, at screening. 2. Weight: ≥60 kg to ≤100 kg, inclusive, at screening. 3. Status: healthy subjects. 4. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 3 months after the last study drug administration. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable. 5. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to each study visit to the clinical research center. 6. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to each study visit to the clinical research center. 7. No presence of any clinically relevant abnormality identified by a detailed medical history and no clinically significant abnormal findings during screening, clinical examination, laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is acceptable), vital signs, and 12-lead ECG. 8. Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Subjects must have signed the ICF before any study-related procedure or evaluation is performed. Exclusion Criteria 1. Previous participation in the current study. 2. Employee of ICON or the Sponsor. 3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). 4. Previous exposure to the study drug (etanercept). 5. History of sensitivity to latex. 6. History or presence of any disease or condition clinically relevant which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary (in light smokers, no signs or symptoms of chronic bronchitis: sputum, recurrent bronchitis or bronchospasm), central nervous, autonomic nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system or psychiatric disorder, as determined by the Investigator. 7. Any current or recent history of active infections, including localized infections (within 2 months prior to the screening visit for any serious infection which requires hospitalization or intravenous (IV) anti infective, and within 14 days prior to the screening visit for known coronavirus disease 2019 (COVID-19) infection (positive antigen or polymerase chain reaction \[PCR\] severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] test) or any active infection which requires anti-infective oral treatment). 8. History of tuberculosis (latent or active); have a positive QuantiFERON-TB Gold test during screening (if QuantiFERON-TB Gold test result is indeterminate, the subject will not be enrolled in this study). 9. Have the intention to travel to regions where tuberculosis and mycosis are endemic diseases within 3 months after dosing. 10. Receipt of live-attenuated or live vaccine within the last 2 months before randomization or planned vaccination (live vaccines) during the study period. 11. Receipt of COVID-19 vaccine within 2 months before randomization; or plans to receive a COVID-19 vaccine within 9 weeks after study first dosing; or presence of COVID-19 symptoms within 3 weeks prior to randomization. 12. Any clinically significant laboratory finding at the time of screening. 13. A negative result for human immunodeficiency virus (HIV) and hepatitis B and C is required for participation (if the subject shows a positive hepatitis B test compatible with prior immunization and not infection, the subject may be included at the discretion of the Investigator). 14. Current malignancy or malignancy within the last 5 years (with the exception of excised non melanoma skin cancer). 15. Active smokers, or who have smoked more than 5 cigarettes a day within the last 12 months prior to start of the study and who have no signs or symptoms of chronic bronchitis. 16. All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center. 17. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) must have been stopped at least 14 days prior to first admission to the clinical research center. An exception is made for paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs), which is allowed up to admission to the clinical research center. 18. Clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to screening, and/or positive alcohol and/or drug test screen confirmed by repeat at screening or check-in. 19. Donation or loss of more than 450 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 L of blood in the 10 months prior to the first drug administration in the current study. 20. Participation in a drug study within 30 days prior to the first drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first drug administration in the current study. 21. Presence of tattoo or scars or any type of skin lesions at the proposed site of injection, that is interfering with the abdominal injection. 22. Subjects who, in the opinion of the Investigator, should not participate in this study.

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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

  • ICON Clinical Research Unit

    Groningen, Provincie Groningen, 9728 NZ, Netherlands

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