Trials / Completed
CompletedNCT03282851
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 696 (actual)
- Sponsor
- Fresenius Kabi SwissBioSim GmbH · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MSB11456 | Subjects will receive a single injection of MSB11456 on Day 1. |
| DRUG | US-licensed Actemra | Subjects will receive a single injection of US-licensed actemra on Day 1. |
| DRUG | EU-approved RoActemra | Subjects will receive a single injection of EU-approved RoActemra on Day 1. |
Timeline
- Start date
- 2017-11-27
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2017-09-14
- Last updated
- 2020-02-12
Locations
2 sites across 1 country: New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03282851. Inclusion in this directory is not an endorsement.