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CompletedNCT01140126Updated Jul 11, 2011

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

A Phase 1 interventional study of Antibody UB-421 in HIV-1 Infection in Adults (Asymptomatic), sponsored by United Biomedical. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-07-11.

Sponsored by United Biomedical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

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.

02

Conditions studied

  • HIV-1 Infection in Adults (Asymptomatic)

Keywords

  • HIV-1, CD4, antibody, immunotherapy
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In context

Lead sponsor

United Biomedical is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Antibody (UB-421)

    Drug: Antibody UB-421

Interventions

  • DrugAntibody UB-421

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

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

2 sites
  • Taipei Veterans General Hospital (TVGH)
    Taipei City, Beitou District 11217, Taiwan
  • Kaohsiung Veterans General Hospital (KVGH)
    Kaohsiung City, Zuoying District 81362, Taiwan
08

References and documents

Publications

  • Wang CY, Sawyer LS, Murthy KK, Fang X, Walfield AM, Ye J, Wang JJ, Chen PD, Li ML, Salas MT, Shen M, Gauduin MC, Boyle RW, Koup RA, Montefiori DC, Mascola JR, Koff WC, Hanson CV. Postexposure immunoprophylaxis of primary isolates by an antibody to HIV receptor complex. Proc Natl Acad Sci U S A. 1999 Aug 31;96(18):10367-72. doi: 10.1073/pnas.96.18.10367. PubMed 10468614 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01140126
Lead sponsor
United Biomedical
First posted
Jun 9, 2010
Start date
May 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Jul 11, 2011

Study contacts

Wing Wai Wong, M.D.
principal investigator · Taipei Veterans General Hospital (TVGH), Taiwan
Hung Chin Tsai, M.D.
principal investigator · Kaohsiung Veterans General Hospital (KVGH), Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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