Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MSB11456; Drug: US-licensed Actemra; Drug: EU-approved RoActemra

• Registration Number: NCT03282851
• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Brief Summary

This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Study Start: 2017-11-27
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

• Healthy male and female subjects, 18 to 55 years of age, with a body mass index (BMI) between 18 and 29.9 kilogram per meter square (kg/m^2).
• Subjects who are on adequate contraception as defined in the protocol and are willing and able to comply with the scheduled study visits, Investigational medicinal product (IMP) administration, safety laboratory tests, and all other study procedures.
• Other protocol defined inclusion criteria could apply.

Exclusion Criteria

• Subjects with history and/or current presence of clinically significant atopic allergy (for example, asthma including childhood asthma, urticaria, angio-edema, eczematous dermatitis).
• Subjects with hypersensitivity or allergic reactions, including known or suspected clinically relevant drug hypersensitivity to any components of the IMP formulations, comparable drugs, or to latex.
• Subjects who have active or latent tuberculosis as indicated by a positive QuantiFERON®-Tuberculosis (TB) Gold test or a history of tuberculosis, lifetime history of invasive systemic fungal infections (for example, histoplasmosis) or other opportunistic infections, including recurrent or chronic local fungal infections, frequent (more than 3 per year requiring treatment) chronic or recurrent infections, having previously been treated with tocilizumab or taken a recombinant monoclonal antibody.
• Subjects who have received a live vaccine within 12 weeks before enrolling in this study or planning for any such vaccination during the study or within 4 months after IMP administration.
• Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSB11456	MSB11456	-
US-licensed Actemra	US-licensed Actemra	-
EU-approved RoActemra	EU-approved RoActemra	-

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48

Secondary Outcome Measures

Name	Time	Method
Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Percentage of Area Under Curve From Zero to Infinity (AUC0-∞) Obtained by Extrapolation (AUC extra%) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Apparent Total Body Clearance of Drug from Serum Following Subcutaneous Administration (CL/F) of MSB11456, US-licensed Actemra, and EU-approved RoActemra	Up to Day 48
Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Injection Site Reactions, Laboratory Variables, Vital Signs and Electrocardiogram (ECG) Measurements	Up to Day 48
Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)	Up to Day 48

Trial Locations

Locations (1)

Research site; 🇳🇿 Christchurch, New Zealand