NCT00612196

CompletedPhase 1

A Phase I Study of Monoclonal Antibody TB-402 in Healthy Mal...

ThromboGenics Source

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Other study identifiers

Sponsor study identifier

TB-402-001

Study Type

interventional

Actual enrollment (reported)

56

Locations

1 country

Sites

1

Timeline

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2007

Actual (reported)

Study Completion

December 2007

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 56 participants
Study completion date: December 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2007
Actual (reported)
Study Completion
December 2007
Actual (reported)
First Submitted
January 9, 2008
Actual (reported)
First Posted
February 11, 2008
Actual (reported)

Last Updated: April 7, 2014
Status Verified: April 2014
Last Update Submitted: April 4, 2014

Conditions

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

123456789

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
No clinically important abnormal physical, laboratory, ECG findings

Sponsors & Collaborators

BioInvent International AB
Industrycollaborator
ThromboGenics
Industrylead

Study Sites (1)

Cyncron Clinical Research Unit

Copenhagen, DK-2100, Denmark

Related Publications (1)

Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.
PMID: 20637972DERIVED

MeSH Terms

Interventions

TB 402

Study Officials

Thomas J Jensen, M.D.
Cyncron Clinical Research Unit
PRINCIPAL INVESTIGATOR

Enrollment

56 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 9, 2008

First Posted

February 11, 2008

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

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Drug

10

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

You may not qualify if:

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%.

Contact the study team to confirm eligibility.

Primary Completion

October 2007

Actual (reported)

Study Completion

December 2007

Actual (reported)

Last Updated

April 7, 2014

Record last verified: 2014-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00612196
Data provider: ClinicalTrials.gov
Source updated: 2014-04-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:33 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Study Arms (10)

1

2

3

4

5

6

7

8

9

10

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations