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

July 7, 2011 updated by: United Biomedical

A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Taiwan
    • Beitou District
      • Taipei City, Beitou District, Taiwan, 11217
        • Taipei Veterans General Hospital (TVGH)
    • Zuoying District
      • Kaohsiung City, Zuoying District, Taiwan, 81362
        • Kaohsiung Veterans General Hospital (KVGH)

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic, treatment-naive, HIV-1 seropositive
  • CD4+ T cell count >350 cells/cubic millimeter
  • HIV-1 viral load >5,000 copies/mL
  • Other inclusion criteria apply

Exclusion Criteria:

  • Active infection requiring immediate therapy (except HIV-1)
  • Prior participation in any HIV vaccine trial
  • Previous exposure to a monoclonal antibody
  • Use of immunomodulating drugs or systemic chemotherapy
  • Other exclusion criteria apply

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antibody (UB-421)
Drug: Antibody UB-421
Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
Time Frame: Screen, treatment & follow-up: 62 to 90 days
Screen, treatment & follow-up: 62 to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.
Time Frame: Screen, treatment & follow-up: 62 to 90 days
Screen, treatment & follow-up: 62 to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Biomedical

Investigators

  • Principal Investigator: Wing Wai Wong, M.D., Taipei Veterans General Hospital (TVGH), Taiwan
  • Principal Investigator: Hung Chin Tsai, M.D., Kaohsiung Veterans General Hospital (KVGH), Taiwan

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.

General Publications

Helpful Links

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

May 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2011

Last Update Submitted That Met QC Criteria

July 7, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBI Protocol A101
  • Protocol A101-HIV (Other Identifier: UBI-Asia)

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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