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Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

NCT01140126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-07-11

No results posted yet for this study

Summary

The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.

Conditions

  • HIV-1 Infection in Adults (Asymptomatic)

Interventions

DRUG

Antibody UB-421

Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

Sponsors & Collaborators

  • United Biomedical

    lead INDUSTRY

Principal Investigators

  • Wing Wai Wong, M.D. · Taipei Veterans General Hospital (TVGH), Taiwan

  • Hung Chin Tsai, M.D. · Kaohsiung Veterans General Hospital (KVGH), Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Taiwan

Study Locations

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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 NCT01140126 on ClinicalTrials.gov