Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Congenital Bleeding DisorderHealthy
Interventions
DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg

DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg

DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg

DRUG

vatreptacog alfa (activated)

One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg

DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg

DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg

DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg

DRUG

placebo

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg

Trial Locations (1)

130-0004

Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00822185 - Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers | Biotech Hunter | Biotech Hunter