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A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

NCT00612196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-04-07

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

TB-402

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

DRUG

Placebo

Sponsors & Collaborators

  • BioInvent International AB

    collaborator INDUSTRY

  • ThromboGenics

    lead INDUSTRY

Principal Investigators

  • Thomas J Jensen, M.D. · Cyncron Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612196 on ClinicalTrials.gov