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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03282851




Registration number
NCT03282851
Ethics application status
Date submitted
30/08/2017
Date registered
14/09/2017
Date last updated
12/02/2020

Titles & IDs
Public title
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
Scientific 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
Secondary ID [1] 0 0
MS200740-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MSB11456
Treatment: Drugs - US-licensed Actemra
Treatment: Drugs - EU-approved RoActemra

Experimental: MSB11456 -

Active comparator: US-licensed Actemra -

Active comparator: EU-approved RoActemra -


Treatment: Drugs: MSB11456
Subjects will receive a single injection of MSB11456 on Day 1.

Treatment: Drugs: US-licensed Actemra
Subjects will receive a single injection of US-licensed actemra on Day 1.

Treatment: Drugs: EU-approved RoActemra
Subjects will receive a single injection of EU-approved RoActemra on Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to Day 48
Primary outcome [2] 0 0
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [2] 0 0
Up to Day 48
Primary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [3] 0 0
Up to Day 48
Secondary outcome [1] 0 0
Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [1] 0 0
Up to Day 48
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to Day 48
Secondary outcome [3] 0 0
Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [3] 0 0
Up to Day 48
Secondary outcome [4] 0 0
Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [4] 0 0
Up to Day 48
Secondary outcome [5] 0 0
Apparent Terminal Rate Constant (?z) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [5] 0 0
Up to Day 48
Secondary outcome [6] 0 0
Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [6] 0 0
Up to Day 48
Secondary outcome [7] 0 0
Apparent Total Body Clearance of Drug from Serum Following Subcutaneous Administration (CL/F) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Timepoint [7] 0 0
Up to Day 48
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Up to Day 48
Secondary outcome [9] 0 0
Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)
Timepoint [9] 0 0
Up to Day 48

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2019
Sample size
Target
Accrual to date
Final
696
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fresenius Kabi SwissBioSim GmbH
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03282851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Fresenius Kabi SwissBioSim GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03282851