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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014