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.
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    tb-402 ...
  • Study Participants

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 Started
Mar 31
Primary Completion
Oct 31
Study Completion
Dec 31
Last Update
Apr 07

Drug TB-402

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

Drug Placebo

1 Experimental

2 Experimental

3 Experimental

4 Experimental

5 Experimental

6 Experimental

7 Experimental

8 Experimental

9 Experimental

10 Placebo Comparator


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%.
No Results Posted