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

Healthy Clinical Trial

Official title:

Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability and Immunogenicity of MSB11456, US-licensed Actemra® and EU-approved RoActemra® in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282851
• Other study ID #: MS200740-0001
• Status: Completed
• Phase: Phase 1
• Start date: November 27, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2020
• Source: Fresenius Kabi SwissBioSim GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 696
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MSB11456
Subjects will receive a single injection of MSB11456 on Day 1.
• US-licensed Actemra
Subjects will receive a single injection of US-licensed actemra on Day 1.
• EU-approved RoActemra
Subjects will receive a single injection of EU-approved RoActemra on Day 1.

Locations

Country	Name	City	State
New Zealand	Research site	Auckland
New Zealand	Research site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi SwissBioSim GmbH

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	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
Secondary	Percentage of Area Under Curve From Zero to Infinity (AUC0-8) Obtained by Extrapolation (AUC extra%) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	Apparent Terminal Rate Constant (?z) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra		Up to Day 48
Secondary	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
Secondary	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
Secondary	Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)		Up to Day 48