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

This study has been completed.
Information provided by:
United Biomedical Identifier:
First received: June 7, 2010
Last updated: July 7, 2011
Last verified: July 2011

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.

Condition Intervention Phase
HIV-1 Infection in Adults (Asymptomatic)
Drug: Antibody UB-421
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by United Biomedical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: N.A.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01140126

Taipei Veterans General Hospital (TVGH)
Taipei City, Beitou District, Taiwan, 11217
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, Zuoying District, Taiwan, 81362
Sponsors and Collaborators
United Biomedical
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
  More Information

Additional Information:
Responsible Party: Wing Wai Wong, M.D., Taipei Veterans General Hospital (TVGH), Taiwan Identifier: NCT01140126     History of Changes
Other Study ID Numbers: UBI Protocol A101, Protocol A101-HIV
Study First Received: June 7, 2010
Last Updated: July 7, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by United Biomedical:
HIV-1, CD4, antibody, immunotherapy

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 23, 2014