Overview

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

Status:
COMPLETED

Trial end date:
2025-05-12

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

mAbxience Research S.L.

Treatments:

Etanercept
etanercept biosimilar SB4