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

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: MB04; Drug: US License Enbrel

• Registration Number: NCT06392074
• Lead Sponsor: mAbxience Research S.L.

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.

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 Timeline

• Study Start: 2024-03-07
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-30
• Primary Completion: 2024-09-17
• Status Verified: 2025-05
• Study Completion: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MB04 (etanercept biosimilar)	MB04	1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept
US licensed Enbrel (etanercept)	US License Enbrel	1 mL pre-filled single-use syringe containing 50 mg (50mg/mL) of etanercept

Primary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax)	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
Area under the serum concentration versus time curve (AUC) from time zero to infinity (AUC0-inf)	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

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax (tmax)	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
Terminal half-life (t½)	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
AUC from time zero to the last quantifiable concentration (AUC0-last)	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
Total body clearance (CL/F)	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
Incidence of anti-etanercept antibodies (ADA) and neutralizing antibodies (Nab)	Day 1 to day 62	Predose and, on Days 7, 14, and 26

Trial Locations

Locations (1)

ICON Clinical Research Unit; 🇳🇱 Groningen, Netherlands