NCT00760565

A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).

A Randomized, Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4905417 Following Intravenous Infusion in Healthy Volunteers and Patients With Peripheral Arterial Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DRUG	RO4905417	3mg/kg iv every 28 days for 3 infusions
DRUG	RO4905417	20mg/kg iv every 28 days for 3 infusions
DRUG	RO4905417	7mg/kg iv every 28 days for 3 infusions
DRUG	placebo	3mg/kg iv every 28 days for 3 infusions
DRUG	placebo	7mg/kg iv every 28 days for 3 infusions
DRUG	placebo	20mg/kg iv every 28 days for 3 infusions

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-09-26
• Last updated: 2016-11-02

Locations

7 sites across 3 countries: United States, Australia, Canada