- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612196
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
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
-
-
-
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
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 2
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 3
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 4
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 5
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 6
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 7
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 8
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Experimental: 9
|
Solution for infusion, 0.015ug/kg-1.8mg/kg,
single dose, iv infusion over 30 minutes
|
Placebo Comparator: 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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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