drugset / Trial / NCT01620931

A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers

NCT01620931 ↗

Phase 1 Completed 36 enrolled Hoffmann-La Roche
RandomizedParallel-groupSingle-blindOther

Summary

This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.

Timeline

Start
2011-11-07
Primary completion
2012-09-03
Completion
2012-09-03

Drugs

EvaluationDrugModalityDoseRoute
Subject RO5469754 Monoclonal antibody — Intravenous

Indications

No indication recorded.