A Phase 1 interventional study of MYL-1402O and US marketed Avastin(R) in Healthy, sponsored by Mylan Inc.. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Mylan Inc. (part of Viatris Inc.) · Phase 1, Interventional, and Other
Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).
Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion of EU marketed Avastin® (1 mg/kg).
Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
First submitted before Mylan Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
MYL-1402O (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Drug: MYL-1402O
US Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Drug: US marketed Avastin(R)
EU Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Drug: EU marketed Avastin(R)
Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.
Also known as: Bevacizumab
Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins
Also known as: Bevacizumab
Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.
Also known as: Bevacizumab
Area under the plasma concentration versus time curve (AUC) for bevacizumab.
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Area under the plasma concentration versus time curve (AUC) for bevacizumab
Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.
Number of Participants with Adverse Events
Number of Participants with Adverse Events
Time frame: up to 99 days.
Safety variable - immunogenicity
Immunogenicity
Time frame: Predose day 1, and days 15, 43, 71, and 99 post infusion
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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