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

April 4, 2014 updated by: ThromboGenics

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Cyncron Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThromboGenics

Collaborators

BioInvent International AB

Investigators

  • Principal Investigator: Thomas J Jensen, M.D., Cyncron Clinical Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TB-402-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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