NCT03282851

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
696

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

August 30, 2017

Last Update Submit

February 10, 2020

Conditions

Healthy

Keywords

MSB11456Actemra®RoActemra®

Outcome Measures

Primary Outcomes (3)

  • 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 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

    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 Reach Maximum Serum Concentration (tmax) 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 Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra

    Up to Day 48

  • +4 more secondary outcomes

Study Arms (3)

MSB11456

EXPERIMENTAL
Drug: MSB11456

US-licensed Actemra

ACTIVE COMPARATOR
Drug: US-licensed Actemra

EU-approved RoActemra

ACTIVE COMPARATOR
Drug: EU-approved RoActemra

Interventions

MSB11456DRUG

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

MSB11456
US-licensed ActemraDRUG

Subjects will receive a single injection of US-licensed actemra on Day 1.

US-licensed Actemra
EU-approved RoActemraDRUG

Subjects will receive a single injection of EU-approved RoActemra on Day 1.

EU-approved RoActemra

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research site

Auckland, New Zealand

Location

Research site

Christchurch, New Zealand

Location

MeSH Terms

Interventions

tocilizumab

Study Officials

  • Medical Responsible

    Fresenius Kabi SwissBioSim GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 14, 2017

Study Start

November 27, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

NZ(2)