Healthy VolunteersPhase 1MB04-A-01-23NCT06392074
A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders
A Phase 1 study testing MB04, US License Enbrel and EU Source Enbrel in people with Healthy Volunteers, run by mAbxience Research S.L. at 1 site in Netherlands.
Trial summary
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®. 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 Volunteers
- What is being tested?
- MB04, US License Enbrel and EU Source Enbrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Mar 2024to 12 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- BMI: 18.5 kg/m2 to 29.9 kg/m2, inclusive, at screening.
- Weight: ≥60 kg to ≤100 kg, inclusive, at screening.
- Status: healthy subjects.
- 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.
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to each study visit to the clinical research center.
- 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.
- 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.
- 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.
Who cannot join
- Previous participation in the current study.
- Employee of ICON or the Sponsor.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Previous exposure to the study drug (etanercept).
- History of sensitivity to latex.
- 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.
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- 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).
- 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).
- Have the intention to travel to regions where tuberculosis and mycosis are endemic diseases within 3 months after dosing.
- Receipt of live-attenuated or live vaccine within the last 2 months before randomization or planned vaccination (live vaccines) during the study period.
- 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.
- Any clinically significant laboratory finding at the time of screening.
- 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).
- Current malignancy or malignancy within the last 5 years (with the exception of excised non melanoma skin cancer).
- 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.
- All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center.
- 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.
- 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.
- 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.
- 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.
- Presence of tattoo or scars or any type of skin lesions at the proposed site of injection, that is interfering with the abdominal injection.
- Subjects who, in the opinion of the Investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ICON Clinical Research Unit
Groningen, Provincie Groningen, 9728 NZ
About this study
Official title: A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (Proposed Etanercept Biosimilar), EU-sourced Enbrel® and US Licensed Enbrel® in Healthy Male Volunteers
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
Read the detailed description
The primary objective of the study is to demonstrate PK similarity between MB04 and EU-Enbrel®, between MB04 and US Enbrel® as well as between EU-Enbrel® and US-Enbrel®. Additional PK parameters will be evaluated as secondary endpoints.
Safety and tolerability will be assessed through Adverse Events, clinical laboratory, vital signs, ECGs, and physical examination findings, and any other parameter that is relevant for safety assessment.
The incidence of ADA to etanercept and the neutralizing potential and titre of positive ADA will be reported
- Conditions
- Healthy Volunteers
- Being tested
- MB04, US License Enbrel, EU Source Enbrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB04Drug
Also called (etanercept biosimilar)
Subcutaneous injection
US License EnbrelDrug
Also called (etanercept)
Subcutaneous injection
EU Source EnbrelDrug
Also called (etanercept)
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MB04 (etanercept biosimilar) | Experimental | 1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept Receives: Drug: MB04 |
| US licensed Enbrel (etanercept) | Active comparator | 1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept Receives: Drug: US License Enbrel |
| EU sourced Enbrel (etanercept) | Active comparator | 1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration versus time curve (AUC) from time zero to infinity (AUC0-inf)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Maximum observed serum concentration (Cmax)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Secondary outcomes (5)
AUC from time zero to the last quantifiable concentration (AUC0-last)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Time to reach Cmax (tmax)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Total body clearance (CL/F)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Terminal half-life (t½)
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Measured: Day 1 to day 62
Incidence of anti-etanercept antibodies (ADA) and neutralizing antibodies (Nab)
Predose and, on Days 7, 14, and 26
Measured: Day 1 to day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start7 Mar 2024
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392074
- Sponsor's protocol ID
- MB04-A-01-23
- Acronym
- MB04-A-01-23
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (Proposed Etanercept Biosimilar), EU-sourced Enbrel® and US Licensed Enbrel® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT06392074
- Acronym / sponsor ID
- MB04-A-01-23 / MB04-A-01-23
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
Detailed description
The primary objective of the study is to demonstrate PK similarity between MB04 and EU-Enbrel®, between MB04 and US Enbrel® as well as between EU-Enbrel® and US-Enbrel®. Additional PK parameters will be evaluated as secondary endpoints.
Safety and tolerability will be assessed through Adverse Events, clinical laboratory, vital signs, ECGs, and physical examination findings, and any other parameter that is relevant for safety assessment.
The incidence of ADA to etanercept and the neutralizing potential and titre of positive ADA will be reported
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MB04 (etanercept biosimilar) | Experimental | Drug: MB041 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept |
| US licensed Enbrel (etanercept) | Active comparator | Drug: US License Enbrel1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept |
| EU sourced Enbrel (etanercept) | Active comparator | –1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI: 18.5 kg/m2 to 29.9 kg/m2, inclusive, at screening.
- Weight: ≥60 kg to ≤100 kg, inclusive, at screening.
- Status: healthy subjects.
- 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.
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to each study visit to the clinical research center.
Key exclusion criteria (22 listed)
- Previous participation in the current study.
- Employee of ICON or the Sponsor.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Previous exposure to the study drug (etanercept).
- History of sensitivity to latex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB04Also: (etanercept biosimilar)Subcutaneous injection | Drug | MB04 (etanercept biosimilar) |
| US License EnbrelAlso: (etanercept)Subcutaneous injection | Drug | US licensed Enbrel (etanercept) |
| EU Source EnbrelAlso: (etanercept)Subcutaneous injection | Drug | – |
Primary outcome
Area under the serum concentration versus time curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: Day 1 to day 62
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
Maximum observed serum concentration (Cmax)
Time frame: Day 1 to day 62
Predose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312, 408, and 600 h post dose
5 secondary outcomes
AUC from time zero to the last quantifiable concentration (AUC0-last)
Time frame: Day 1 to day 62
Time to reach Cmax (tmax)
Time frame: Day 1 to day 62
Total body clearance (CL/F)
Time frame: Day 1 to day 62
Terminal half-life (t½)
Time frame: Day 1 to day 62
Incidence of anti-etanercept antibodies (ADA) and neutralizing antibodies (Nab)
Time frame: Day 1 to day 62
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB04, US License Enbrel and EU Source Enbrel in people with Healthy Volunteers, run by mAbxience Research S.L. at 1 site in Netherlands.
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 8 inclusion and 22 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 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the serum concentration versus time curve (AUC) from time zero to infinity (AUC0-inf) (time frame: Day 1 to day 62). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.