This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
603
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
QOPK Phase 1 Clinic
Overland Park, Kansas, United States
QLON Phase 1 Clinic
London, United Kingdom
Pharmacokinetics: Area under the concentration-time curve from 0 to infinity
Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinity \[AUC(0-inf)\]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve from 0 to 336 hours
Area under the concentration-time curve in serum from time zero (predose) to 336 hours postdose \[AUC(0-336)\]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, and 15
Pharmacokinetics: Maximum concentration in serum (Cmax)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Serum M923 concentration up to Day 71
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to 1200 hours postdose [AUC(0-1200)]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, and 50
Pharmacokinetics: Area under the concentration-time curve in serum from time zero (predose) to time of the last quantifiable concentration [AUC(0-last)]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Time of maximum concentration in serum [tmax]
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Obtained directly from the observed concentration versus time data
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal rate constant (λ z)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Terminal half-life (t½)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Apparent systemic clearance after extravascular dosing (CL/F)
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the concentration-time curve extrapolated from time "t" to infinity [% AUCex]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Pharmacokinetics: Area under the serum concentration-time curves from time zero (predose) to time "t" [AUC(0-t)] by which >20.0% of participants have developed neutralizing antidrug antibody [nADA]
Time frame: Within 90 minutes pre-dose; and post-dose at 8 hours, and Day 2, 3, 4, 5, 6, 7, 9, 11, 15, 22, 29, 40, 50, and 71
Non-serious and serious adverse events (SAEs)
Time frame: Throughout the study period of approximately 8 months
Incidence of injection site reactions
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in Vital signs
Time frame: Throughout the study period of approximately 8 months
Number of participants with new clinically significant findings from the physical examination
Physical examination will be done on the following body systems: general appearance, head and neck, eyes and ears, nose and throat, chest, lungs, heart, abdomen, extremities and joints, lymph nodes, skin, and neurological.
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in Twelve-lead electrocardiogram (ECG)
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in laboratory results
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in clinical chemistry
Time frame: Throughout the study period of approximately 8 months
Clinically significant changes in urinalysis
Time frame: Throughout the study period of approximately 8 months