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

Fresenius Kabi SwissBioSim GmbH2 sites in 1 country216 target enrollmentJuly 15, 2019

ConditionsRheumatoid 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

Interventions40 mg MSB11022

Drugs40 mg MSB11022

Overview

Phase: Phase 1
Intervention: 40 mg MSB11022
Conditions: Rheumatoid Arthritis
Sponsor: Fresenius Kabi SwissBioSim GmbH
Enrollment: 216
Locations: 2
Primary Endpoint: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) for MSB11022
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 15, 2019

End Date

March 17, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fresenius Kabi SwissBioSim GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to sign the informed consent form (ICF).
•Healthy male subjects and female subjects of non-childbearing and childbearing potential.
•Aged 18 to 55 years, inclusive, at screening.
•Have all screening results (vital signs, physical examination, clinical laboratory tests, 12-lead ECG) within the normal range or outside the normal range but assessed as not clinically significant by the Investigator.
•Body weight between 50.0 and 100.0 kg, inclusive, and a body mass index between 18.5 and 30.0 kg/m2, inclusive.
•Male subjects must be either surgically sterile or willing to use contraceptive methods until 5 months after the dose of investigational medicinal product (IMP).
•Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and before randomization. WOCBP must agree to use highly effective methods of contraception to prevent pregnancy for at least 4 weeks before randomization until 5 months after the dose of IMP. For all postmenopausal female subjects, serum follicle-stimulating hormone (FSH) is tested at screening to identify their postmenopausal status.
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests and all other study procedures.

Exclusion Criteria

•Female subjects must not be pregnant or lactating at screening through at least 5 months after the last treatment with IMP.
•A history and/or current presence of clinically significant atopic allergy (eg, asthma including childhood asthma), hypersensitivity or allergic reactions (either spontaneous or following drug administration), including known or suspected clinically relevant drug hypersensitivity to any components of the study drug formulations, comparable drugs, or to latex. Mild hay fever is allowed if outside of acute exacerbation requiring treatment. Assessment of clinical significance of reported atopic or allergic condition in medical history of participant is at Investigator decision.
•Have either active or latent tuberculosis (TB) as indicated by a positive QuantiFERON®-TB Gold test or have a history of TB. Subjects who have an indeterminate QuantiFERON-TB Gold test result may be re-tested once during screening. If the re-test result is negative, the subject is eligible to participate in the study. If the re-test result is indeterminate again or positive, the subject is NOT eligible to participate in the study.
•Lifetime history of invasive systemic fungal infections (eg, histoplasmosis) or other opportunistic infections, including recurrent or chronic local fungal infections.
•Have had a serious infection (associated with hospitalization and/or which required intravenous anti-infectives or intravenous antibiotics) within 6 months prior to study drug administration and/or a significant infection (excluding resolved infections like a mild common cold) within 2 weeks prior to the screening or during the screening period unless the infection has resolved completely within 2 weeks before admission.
•Have had herpes zoster
•within the last year, or
•more than 2 herpes zoster infections in their lifetime prior to randomization.
•History or presence (at time of screening or randomization) of frequent (ie, requiring treatment more than 3 times a year), chronic or recurrent infections.
•Have previously been exposed to adalimumab or approved or proposed adalimumab biosimilar drugs if known. Have been exposed to any anti-tumor necrosis factor alfa class drug whether approved drug or investigational drug\\proposed biosimilar.

Arms & Interventions

40 mg MSB11022 via Auto-injector

Participants will receive a single dose of 40 mg/0.8 mL of MSB11022 via an auto-injector on Day 1.

Intervention: 40 mg MSB11022

40 mg MSB11022 via Pre-filled Syringe

Participants will receive a single dose of 40 mg/0.8 mL of MSB11022 via a pre-filled syringe on Day 1.

Intervention: 40 mg MSB11022

Outcomes

Primary Outcomes

Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) for MSB11022

Time Frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for MSB11022

Time Frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose

Maximum Observed Plasma Concentration (Cmax) for MSB11022

Time Frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose

Secondary Outcomes

Number of Participants with at Least One Adverse Event of Special Interest (AESI)(Screening (up to 28 days prior to study admission) to Day 71)
Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Results(Screening (up to 28 days prior to study admission) to Day 71)
Number of Participants who Experience a Clinically Significant Change in Electrocardiogram (ECG) Results(Screening (up to 28 days prior to study admission) to Day 71)
Terminal Rate Constant (λz) for MSB11022(Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose)
Terminal Half-life (t1/2) for MSB11022(Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose)
Number of Participants with at Least One Serious Adverse Event (SAE)(Screening (up to 28 days prior to study admission) to Day 71)
Number of Participants with an Injection Site Reaction (ISR)(Day 1 (post-dose) to Day 71)
Apparent Total Clearance (CL/F) for MSB11022(Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose)
Number of Participants with at Least One Treatment-Emergent Adverse Event (TEAE)(Day 1 (post-dose) to Day 71)
Number of Participants who Experience a Clinically Significant Change in Vital Sign Results(Screening (up to 28 days prior to study admission) to Day 71)
Time to Reach the Maximum Plasma Concentration (Tmax) for MSB11022(Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose)