A Phase 1 interventional study of MHAA4549A and MHAA4549A in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Other
This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MHAA4549A
Drug: MHAA4549A
Drug: Placebo
MHAA4549A single, intravenous dose administration, lower dose level
MHAA4549A single, intravenous dose administration, higher dose level
Matching placebo to MHAA4549A administration
Incidence and nature of adverse events (AEs)
Time frame: Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAA4549A administration
Time frame: From baseline to end of study, up to 120 days
Changes in ECG findings during and following MHAA4549A administration
Time frame: From baseline to end of study, up to 120 days
Severity of AEs
Time frame: Until study discontinuation/termination, up to 120 days
Pharmacokinetics (composite outcome measure): parameters derived from the nasal and serum concentration-time profile of MHAA4549A (area under the concentration-time curve [AUC], Cmax, tmax, clearance, Vss, half-life (t1/2), mean residence time)
Time frame: Up to 120 days
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.