A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders

NCT06392074 | Completed Phase 1 FDA Drug

• 1 other identifier: MB04-A-01-23
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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®. 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 1 to day 62

Secondary Outcomes (5)

• AUC from time zero to the last quantifiable concentration (AUC0-last)

  Day 1 to day 62

• Time to reach Cmax (tmax)

  Day 1 to day 62

• Total body clearance (CL/F)

  Day 1 to day 62

• Terminal half-life (t½)

  Day 1 to day 62

• Incidence of anti-etanercept antibodies (ADA) and neutralizing antibodies (Nab)

  Day 1 to day 62

Study Arms (3)

MB04 (etanercept biosimilar)

EXPERIMENTAL

1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept

Drug: MB04

US licensed Enbrel (etanercept)

ACTIVE COMPARATOR

1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept

Drug: US License Enbrel

EU sourced Enbrel (etanercept)

ACTIVE COMPARATOR

1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept

Interventions

MB04 DRUG

Subcutaneous injection

Also known as: (etanercept biosimilar)

MB04 (etanercept biosimilar)

US License Enbrel DRUG

Subcutaneous injection

Also known as: (etanercept)

US licensed Enbrel (etanercept)

EU Source Enbrel DRUG

Subcutaneous injection

Also known as: (etanercept)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (1)

ICON Clinical Research Unit

Groningen, Provincie Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

etanercept biosimilar SB4; Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 30, 2024
• Study Start: March 7, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

NL (1)