A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
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.
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Mar 2007
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 9, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedApril 7, 2014
April 1, 2014
7 months
January 9, 2008
April 4, 2014
Conditions
Keywords
Study Arms (10)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTAL8
EXPERIMENTAL9
EXPERIMENTAL10
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
- 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.
Sponsors & Collaborators
- ThromboGenicslead
- BioInvent International ABcollaborator
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
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J Jensen, M.D.
Cyncron Clinical Research Unit
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 1, 2007
Primary Completion
October 1, 2007
Study Completion
December 1, 2007
Last Updated
April 7, 2014
Record last verified: 2014-04