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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612196
• Other study ID #: TB-402-001
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2008
• Last updated: April 4, 2014
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TB-402
Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes
• Placebo

Locations

Country	Name	City	State
Denmark	Cyncron Clinical Research Unit	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
ThromboGenics	BioInvent International AB

Country where clinical trial is conducted

Denmark,