drugset
drugset / Trial / NCT06392074

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 ↗

Phase 1 Completed 141 enrolled mAbxience Research S.L.
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2024-03-07
Primary completion
2025-05-12
Completion
2025-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic 50 mg Subcutaneous

Indications

No indication recorded.