A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Congenital Bleeding DisorderHaemophilia AHaemophilia BHealthy
Interventions
DRUG

activated recombinant human factor VII, long acting

Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.

DRUG

placebo

Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.

DRUG

activated recombinant human factor VII, long acting

Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

Trial Locations (1)

HA1 3UJ

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Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY