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

NCT00951873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-05-13

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
  • Healthy

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).

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951873 on ClinicalTrials.gov