A Phase 1 interventional study of M923 in Healthy, sponsored by Momenta Pharmaceuticals, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Momenta Pharmaceuticals, Inc. · Phase 1, Interventional, and Other
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.
Momenta Pharmaceuticals, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy male participants must be willing to comply with the contraception restrictions for this study.
-Male participants with non-pregnant female partners of childbearing potential should avoid conception of a child during the study (up to Day 71 post-dose) and for 90 days thereafter.
Healthy female participants must have a negative pregnancy test at screening and on admission to the study site (Day -1), must not be lactating and must be using an acceptable method of contraception throughout the study and for 30 days after study completion, or be of non-childbearing potential.
-Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.
Exclusion Criteria:
M923 administered via AI
Biological: M923
M923 administered via PFS
Biological: M923
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Also known as: Adalimumab
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]
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
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Momenta Pharmaceuticals, Inc.