New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
NCT Number: NCT02820896
This is a Phase I, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7105705 in two participant populations: healthy participants and participants with mild-to-moderate Alzheimer's disease. This study is a single dose, dose-escalation, and multiple dose study comprising approximately six single dose cohorts in healthy participants administered RO7105705, either intravenously (IV) or subcutaneously (SC), and comprising one or more multiple dose cohorts in healthy participants administered RO7105705 IV every week (QW), a total of 4 doses, and one or more multiple dose cohorts in participants with Alzheimer's disease administered RO7105705 IV QW, a total of 4 doses.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Knoxville, Tennessee, 37920, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants
Healthy Participants
Participants who enroll into a cohort that requires lumbar puncture
Participants with Alzheimer's disease
Exclusion criteria
Any participants
Participants with Alzheimer's disease
Participants will receive single or multiple doses of RO7105705 matching placebo IV.
Participants will receive single or multiple doses of RO7105705 IV or SC.
Time frame: Screening up to Day 134
Time frame: Day 1 up to Day 36
Time frame: Baseline, up to approximately 134 days
Time frame: Baseline, Week 19
Time frame: Baseline, Days 29, 57, 113
Time frame: Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Day 1, Days 2, 3, 8, 15, 29, 43, 57, 85, 113
Time frame: Pre-dose, Hour 4, 8, 12 on Day 1, Days 2, 3, 4, 6, 8, 15, 29, 43, 57, 85, 113
Time frame: Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Days 1, 8 15, 22, Days 2, 3, 23, 29, 36, 50, 64, 78, 106, 134
Time frame: Baseline, Week 19
Genentech, Inc.
Industry
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous and Subcutaneous RO7105705 Administered in Healthy Volunteers and Patients With Mild-to-Moderate Alzheimer's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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