Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS

NCT04018599 | Completed Phase 1 FDA Drug

• 1 other identifier: FKS022-001
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

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

Keywords

Biosimilar; Adalimumab; MSB11022

Outcome Measures

Primary Outcomes (3)

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

• Maximum Observed Plasma Concentration (Cmax) 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

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

Secondary Outcomes (11)

• 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

• 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

• 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

Study Arms (2)

40 mg MSB11022 via Auto-injector

EXPERIMENTAL

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

Drug: 40 mg MSB11022

40 mg MSB11022 via Pre-filled Syringe

EXPERIMENTAL

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

Drug: 40 mg MSB11022

Interventions

40 mg MSB11022 DRUG

Single dose, as a solution, administered subcutaneously, using an auto-injector.

40 mg MSB11022 via Auto-injector

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Intake of an investigational drug in another study within 3 months or 5 half-lives, whichever is longer, before the intake of the IMP in this study or planned intake of an investigational drug during the course of this study.
• Use of depot injectable solutions (except for depot contraception drugs) within 6 months before randomization.
• Smoking more than equivalent of (as determined by investigator) 10 cigarettes per day and/or inability to refrain from smoking or consuming nicotine containing products during the residential stay at the trial site.
• History of alcohol abuse within one year from screening and/or inability to refrain from intake of alcoholic beverages from 48 hours prior to Day -1 until Day 14 postdose or a positive screen for alcohol on admission to the clinical site prior to study drug administration.
• Positive screen for drugs of abuse at screening or at admission to the clinical site prior to study drug administration.

Sponsors & Collaborators

• Fresenius Kabi SwissBioSim GmbH: lead
• PRA Health Sciences: collaborator

Study Sites (2)

PRA Health Sciences (PRA) - Early Development Services (EDS)

Lenexa, Kansas, 66219, United States

Location

PRA-EDS

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Sabet A, Dickerson DS, Kunina EE, Buccarello AL, Monnet J. A Randomised Controlled Trial Comparing the Pharmacokinetics and Tolerability of the Proposed Adalimumab Biosimilar MSB11022 Delivered via Autoinjector and Pre-filled Syringe in Healthy Subjects. Rheumatol Ther. 2022 Apr;9(2):693-704. doi: 10.1007/s40744-022-00432-1. Epub 2022 Mar 9.

  PMID: 35262901 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Juvenile; Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases

Study Officials

• Radmila Kanceva, MD, PhD

  Fresenius Kabi SwissBioSim GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 12, 2019
• Study Start: July 15, 2019
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (2)