A Phase 1 interventional study of Gantenerumab and Placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
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:
Participants will receive a single SC dose of gantenerumab on Day 1.
Drug: Gantenerumab
Participants will receive a single SC dose of matching placebo on Day 1.
Drug: Placebo
Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I.
Drug: Gantenerumab
Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
Percentage of participants with adverse events (AEs)
Time frame: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
Maximum observed plasma concentration (Cmax) of gantenerumab
Time frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Area under the plasma concentration-time curve (AUC) of gantenerumab
Time frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche