Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS (NCT04018599) | Clinical Trial Compass
CompletedPhase 1
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
United States216 participantsStarted 2019-07-15
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
✕
What they're measuring
1
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) for MSB11022
. 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.