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

Phase 1
Completed
Conditions
Peripheral Arterial Disease (PAD)
Interventions
Drug: RO4905417
Drug: placebo
Registration Number
NCT00760565
Lead Sponsor
Hoffmann-La Roche
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
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).
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
7RO4905417-
8placebo-
4placebo-
10placebo-
5RO4905417-
1RO4905417-
6placebo-
11RO4905417-
3RO4905417-
12placebo-
2placebo-
9RO4905417-
Primary Outcome Measures
NameTimeMethod
Safety: Adverse events; clinical laboratory tests; physical examination; vital signs including ECG.Throughout study
Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics of RO4905417Throughout study
Pharmacodynamics: bleeding time; protein/vascular markersThroughout study
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