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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00760565

Enrollment

Registered

2008-09-26

Start date

2008-09-30

Completion date

2011-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease (PAD)

Brief 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.

Interventions

DRUGRO4905417

3mg/kg iv every 28 days for 3 infusions

DRUGplacebo

3mg/kg iv every 28 days for 3 infusions

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10); * BMI 18-30kg/m2 (Arms 1,2,5,6,9,10); * males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12); * on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12); * BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).

Exclusion criteria

* patients with pain at rest and/or local complications; * history of any cardiovascular event within the previous 6 months; * treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel); * evidence of hepatic or renal impairment; * history of bleeding disorders.

Design outcomes

Primary

Measure	Time frame
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.	Throughout study

Secondary

Measure	Time frame
Pharmacodynamics: bleeding time; protein/vascular markers	Throughout study
Pharmacokinetics of RO4905417	Throughout study

Countries

Australia, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026