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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04018599
Date of registration: 11/07/2019
Prospective Registration: Yes
Primary sponsor: Fresenius Kabi SwissBioSim GmbH
Public title: Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
Scientific title: 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
Date of first enrolment: July 15, 2019
Target sample size: 216
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT04018599
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Radmila Kanceva, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Fresenius Kabi SwissBioSim GmbH
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Willing and able to sign the informed consent form (ICF).

2. Healthy male subjects and female subjects of non-childbearing and childbearing
potential.

3. Aged 18 to 55 years, inclusive, at screening.

4. 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.

5. Body weight between 50.0 and 100.0 kg, inclusive, and a body mass index between 18.5
and 30.0 kg/m2, inclusive.

6. Male subjects must be either surgically sterile or willing to use contraceptive
methods until 5 months after the dose of investigational medicinal product (IMP).

7. 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.

8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
all other study procedures.

Exclusion Criteria:

1. Female subjects must not be pregnant or lactating at screening through at least 5
months after the last treatment with IMP.

2. 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.

3. 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.

4. Lifetime history of invasive systemic fungal infections (eg, histoplasmosis) or other
opportunistic infections, including recurrent or chronic local fungal infections.

5. 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.

6. Have had herpes zoster

1. within the last year, or

2. more than 2 herpes zoster infections in their lifetime prior to randomization.

7. History or presence (at time of screening or randomization) of frequent (ie, requiring
treatment more than 3 times a year), chronic or recurrent infections.

8. 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.

9. 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.

10. Use of depot injectable solutions (except for depot contraception drugs) within 6
months before randomization.

11. 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.

12. 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.

13. Positive screen for drugs of abuse at screening or at admission to the clinical site
prior to study drug administration.

14. Donated more than 450 mL of blood within 60 days or 450 mL of blood products (eg,
plasma, platelets) within 2 weeks prior to admission to the clinical site or intend to
donate during the study.

15. Use of any prescribed or non-prescribed medication including antacids, analgesics
(other than paracetamol/acetaminophen), dietary supplements or herbal medication
during the 2 weeks prior to study drug administration or longer if the medication has
a long half-life. For female subjects, oral contraceptives and hormone replacement
therapy are allowed.

16. History of cancer including lymphoma, leukemia, and skin cancer.

17. Impaired liver function as determined at screening or admission to the clinic by one
of the following:

- Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5
times the upper limit of normal (ULN) at screening or admission to the clinic.

- A positive hepatitis C virus (HCV) antibody test or hepatitis B surface antigen
(HBsAg) test and/or core antibody test for immunoglobulin G (IgG) and/or
immunoglobulin M (IgM) at screening.

18. History of or current signs or symptoms of demyelinating disease including optic
neuritis and/or multiple sclerosis.

19. History of immunodeficiency (including a positive test for human immunodeficiency
virus [HIV] 1 or 2 antibodies) or other clinically significant immunological
disorders, or autoimmune disorders, (eg, rheumatoid arthritis, lupus erythematosus,
scleroderma).

20. History of and/or current gastrointestinal, renal, cardiovascular, hematological
(including pancytopenia, aplastic anemia or blood dyscrasia), metabolic (including
known diabetes mellitus), central nervous system or pulmonary disease considered as
significant by the Investigator.

21. Received a live vacci



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Crohn Disease
Hidradenitis Suppurativa
Non-infectious Uveitis
Pediatric Crohns Disease
Pediatric Plaque Psoriasis
Plaque Psoriasis
Polyarticular Juvenile Idiopathic Arthritis
Psoriatic Arthritis
Rheumatoid Arthritis
Ulcerative Colitis
Intervention(s)
Drug: 40 mg MSB11022
Primary Outcome(s)
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 Outcome(s)
Apparent Total Clearance (CL/F) 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]
Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Results [Time Frame: 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 [Time Frame: Screening (up to 28 days prior to study admission) to Day 71]
Number of Participants who Experience a Clinically Significant Change in Vital Sign Results [Time Frame: Screening (up to 28 days prior to study admission) to Day 71]
Number of Participants with an Injection Site Reaction (ISR) [Time Frame: Day 1 (post-dose) to Day 71]
Number of Participants with at Least One Adverse Event of Special Interest (AESI) [Time Frame: Screening (up to 28 days prior to study admission) to Day 71]
Number of Participants with at Least One Serious Adverse Event (SAE) [Time Frame: Screening (up to 28 days prior to study admission) to Day 71]
Number of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) [Time Frame: Day 1 (post-dose) to Day 71]
Terminal Half-life (t1/2) 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]
Terminal Rate Constant (?z) 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]
Time to Reach the Maximum Plasma Concentration (Tmax) 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 ID(s)
FKS022-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
PRA Health Sciences
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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