A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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.