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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507877-17-00
Acronym
MB04-A-01-23
Enrollment
132
Registered
2024-01-25
Start date
2024-02-12
Completion date
2025-06-04
Last updated
2025-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Not applicable

Interventions

None listed

Sponsors

Mabxience Research S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026