NCT02820896

A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive single or multiple doses of RO7105705 matching placebo IV.
DRUG	RO7105705	Participants will receive single or multiple doses of RO7105705 IV or SC.

Timeline

• Start date: 2016-06-29
• Primary completion: 2017-06-26
• Completion: 2017-06-26
• First posted: 2016-07-01
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States