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

Roche

Status and phase: Completed; Phase 1

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Drug: RO4905417; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760565

BP21617

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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72 participants in 12 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417

10

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

11

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417

12

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

3

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417

4

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

5

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417

6

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

7

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417

8

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

9

Experimental group

Treatment:

Drug: RO4905417

Drug: RO4905417

Drug: RO4905417