A Phase 1 interventional study of Placebo and RO6926496 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
8 volunteers (6 active, 2 placebo)
Drug: Placebo · Drug: RO6926496
Matching placebo to RO6926496
single, ascending dose, intravenous administration
Incidence of adverse events (AEs)
Time frame: Up to 16 weeks
Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance
Time frame: Up to 16 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche