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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612196

Enrollment

Registered

2008-02-11

Start date

2007-03-31

Completion date

2007-12-31

Last updated

2014-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety and tolerability

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.

Interventions

DRUGTB-402

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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%.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026