HealthyPhase 1NCT03282851
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
A Phase 1 study testing MSB11456, US-licensed Actemra and EU-approved RoActemra in people with Healthy, run by Fresenius Kabi SwissBioSim GmbH at 2 sites in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MSB11456, US-licensed Actemra and EU-approved RoActemra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 27 Nov 2017to 1 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- MSB11456, US-licensed Actemra, EU-approved RoActemra
- Keywords
- MSB11456, Actemra®, RoActemra®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSB11456Drug
Subjects will receive a single injection of MSB11456 on Day 1.
US-licensed ActemraDrug
Subjects will receive a single injection of US-licensed actemra on Day 1.
EU-approved RoActemraDrug
Subjects will receive a single injection of EU-approved RoActemra on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| MSB11456 | Experimental | Not described Receives: Drug: MSB11456 |
| US-licensed Actemra | Active comparator | Not described Receives: Drug: US-licensed Actemra |
| EU-approved RoActemra | Active comparator | Not described Receives: Drug: EU-approved RoActemra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to Day 48
Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: Up to Day 48
Secondary outcomes (9)
Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: 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
Measured: Up to Day 48
Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: Up to Day 48
Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: Up to Day 48
Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: Up to Day 48
Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Measured: 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
Measured: 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
Measured: Up to Day 48
Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)
Measured: Up to Day 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start27 Nov 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Fresenius Kabi SwissBioSim GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282851
- Sponsor's protocol ID
- MS200740-0001
- Status last verified
- Feb 2020
- First submitted
- 30 Aug 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03282851
- Acronym / sponsor ID
- MS200740-0001
- Conditions
- Healthy
- Keywords
- MSB11456, Actemra®, RoActemra®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSB11456 | Experimental | Drug: MSB11456 |
| US-licensed Actemra | Active comparator | Drug: US-licensed Actemra |
| EU-approved RoActemra | Active comparator | Drug: EU-approved RoActemra |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSB11456Subjects will receive a single injection of MSB11456 on Day 1. | Drug | MSB11456 |
| US-licensed ActemraSubjects will receive a single injection of US-licensed actemra on Day 1. | Drug | US-licensed Actemra |
| EU-approved RoActemraSubjects will receive a single injection of EU-approved RoActemra on Day 1. | Drug | EU-approved RoActemra |
Primary outcome
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
Time frame: 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
Time frame: Up to Day 48
Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
9 secondary outcomes
Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: 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
Time frame: Up to Day 48
Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: Up to Day 48
Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra
Time frame: 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
Time frame: 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
Time frame: Up to Day 48
Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)
Time frame: Up to Day 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Fresenius Kabi SwissBioSim GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSB11456, US-licensed Actemra and EU-approved RoActemra in people with Healthy, run by Fresenius Kabi SwissBioSim GmbH at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to Day 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.