A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Collaborator:
BioInvent International AB
Information provided by:
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00612196
First received: January 9, 2008
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: TB-402
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.

Further study details as provided by ThromboGenics:

Enrollment: 56
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 2 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 3 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 4 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 5 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 6 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 7 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 8 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Experimental: 9 Drug: TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
Placebo Comparator: 10 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
  • No clinically important abnormal physical, laboratory, ECG findings
  • Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion Criteria:

  • Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
  • Any autoimmune disease.
  • Previous allergic reaction to immunoglobulin.
  • Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
  • Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
  • Abnormal platelet function or clinically significant out of range values for any coagulation tests.
  • History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
  • Screening FVIII:C < 50%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612196

Locations
Denmark
Cyncron Clinical Research Unit
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
ThromboGenics
BioInvent International AB
Investigators
Principal Investigator: Thomas J Jensen, M.D. Cyncron Clinical Research Unit
  More Information

No publications provided

Responsible Party: Geraldine Cahillane, ThromboGenics Ltd.
ClinicalTrials.gov Identifier: NCT00612196     History of Changes
Other Study ID Numbers: TB-402-001
Study First Received: January 9, 2008
Last Updated: April 4, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by ThromboGenics:
Safety and tolerability

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014