Trials / Completed
CompletedNCT04018599
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Fresenius Kabi SwissBioSim GmbH · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection of 40 mg.
Conditions
- Rheumatoid Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn Disease
- Ulcerative Colitis
- Plaque Psoriasis
- Pediatric Plaque Psoriasis
- Pediatric Crohns Disease
- Hidradenitis Suppurativa
- Non-infectious Uveitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 40 mg MSB11022 | Single dose, as a solution, administered subcutaneously, using an auto-injector. |
| DRUG | 40 mg MSB11022 | Single dose, as a solution, administered subcutaneously, using a pre-filled syringe. |
Timeline
- Start date
- 2019-07-15
- Primary completion
- 2020-03-17
- Completion
- 2020-03-17
- First posted
- 2019-07-12
- Last updated
- 2020-03-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04018599. Inclusion in this directory is not an endorsement.